yuletide [0.001):<0.007) different from placebo Significantly (p> <0.002) different from placebo US Trial EU Trial Placebo ( n = 37 ) 0 . 5 mg E 2 * ( n = 31 ) Amabelz 1 . 0 mg / 0 . 5 mg ( n = 37 ) Placebo ( n = 40 ) Amabelz 1 . 0 mg / 0 . 5 mg ( n = 38 ) Lumbar spine Femoral neck Femoral trochanter -2.1 2.9 -2.3 3.4 -2.0 4.3 2.3 2.8 0.3 2.9 1.7 4.1 3.8 3.0 1.8 4.1 3.7 4.3 -0.9 4.0 -1.0 4.6 0.8 6.9 5.4 4.8 0.7 6.1 6.3 7.6 The overall difference in mean percentage change in BMD at the lumbar spine in the US trial (1000 mg per day calcium) between Amabelz 1 mg/0.5 mg and placebo was 5.9 percent and between estradiol 0.5 mg and placebo was 4.4 percent. In the European trial (500 mg per day calcium), the overall difference in mean percentage change in BMD at the lumbar spine was 6.3 percent. Amabelz 1 mg/0.5 mg and estradiol 0.5 mg also increased BMD at the femoral neck and femoral trochanter compared to placebo. The increase in lumbar spine BMD in the US and European clinical trials for Amabelz 1 mg/0.5 mg and estradiol 0.5 mg is displayed in Figure 6. Figure 6 Percentage Change in Bone Mineral Density (BMD) SEM of the Lumbar Spine (L1-L4) for Amabelz 1 mg/0.5 mg and Estradiol 0.5 mg (Intent to Treat Analysis with Last Observation Carried Forward) Women s Health Initiative Studies The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of CHD (defined as nonfatal MI, silent MI and CHD death), with invasive breast cancer as the primary adverse outcome. A "global index" included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. These substudies did not evaluate the effects of CE plus MPA or CE-alone on menopausal symptoms. WHI Estrogen Plus Progestin Substudy The WHI estrogen plus progestin substudy was stopped early. According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of invasive breast cancer and cardiovascular events exceeded the specified benefits included in the "global index." The absolute excess risk of events included in the "global index" was 19 per 10,000 women-years. For those outcomes included in the WHI "global index," that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE plus MPA were 7 more CHD events, 8 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reductions per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures. Results of the CE plus MPA substudy, which included 16,608 women (average 63 years of age, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 6. These results reflect centrally adjudicated data after an average follow-up of 5.6 years. TABLE 6: RELATIVE AND ABSOLUTE RISK SEEN IN THE ESTROGEN PLUS PROGESTIN SUBSTUDY OF WHI AT AN AVERAGE OF 5.6 YEARS * , * Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. Results are based on centrally adjudicated data. Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. Not included in global index . Includes metastatic and non-metastatic breast cancer, with the exception of in situ breast cancer. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a global index defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes. Event Relative Risk CE / MPA vs . Placebo ( 95 % nCI ) CE / MPA n = 8 , 506 Placebo n = 8 , 102 Absolute Risk per 10 , 000 Women - Years CHD events Non - fatal MI CHD death All strokes Ischemic stroke Deep vein thrombosis Pulmonary embolism Invasive breast cancer Colorectal cancer Endometrial cancer Cervical cancer Hip fracture Vertebral fractures Lower arm/wrist fractures Total fractures Overall Mortality # Global Index Þ 1.23 (0.99-1.53) 1 . 28 ( 1 . 00 - 1 . 63 ) 1 . 10 ( 0 . 70 - 1 . 75 ) 1.31 (1.02 1.68) 1 . 44 ( 1 . 09 1 . 90 ) 1.95 (1.43 2.67) 2.13 (1.45 3.11) 1.24 (1.01 1.54) 0.61 (0.42 0.87) 0.81 (0.48 1.36) 1.44 (0.47 4.42) 0.67 (0.47 0.96) 0.65 (0.46 0.92) 0.71 (0.59 0.85) 0.76 (0.69 0.83) 1.00 (0.83-1.19) 1.13 (1.02-1.25) 41 31 8 33 26 26 18 41 10 6 2 11 11 44 152 52 184 34 25 8 25 18 13 8 33 16 7 1 16 17 62 199 52 165 Timing of the initiation of estrogen plus progestin therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen plus progestin substudy, stratified by age, showed in women 50 to 59 years of age a non-significant trend toward reduced risk for overall mortality [hazard ratio (HR) 0.69 (95 percent CI, 0.44 to 1.07)]. WHI Estrogen-Alone Substudy The WHI estrogen-alone substudy was stopped early because an increased risk of stroke was observed, and it was deemed that no further information would be obtained regarding the risks and benefits of estrogen-alone in predetermined primary endpoints. Results of the estrogen-alone substudy, which included 10,739 women (average 63 years of age, range 50 to 79; 75.3 percent White, 15.1 percent Black, 6.1 percent Hispanic, 3.6 percent Other), after an average follow-up of 7.1 years, are presented in Table 7. Table 7: Relative and Absolute Risk Seen in the Estrogen-Alone Substudy of WHI * * Adapted from numerous WHI publications. WHI publications can be viewed at www.nhlbi.nih.gov/whi. Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. Results are based on centrally adjudicated data for an average follow-up of 7.1 years. Not included in global index . Results are based on an average follow-up of 6.8 years. # All deaths, except from breast or colorectal cancer, definite or probable CHD, PE or cerebrovascular disease. Þ A subset of the events was combined in a global index, defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes. Event Relative Risk CE vs . Placebo ( 95 % nCI ) CE n = 5 , 310 Placebo n = 5 , 429 Absolute Risk per 10 , 000 Women - years CHD events 0.95 (0.78 1.16) 54 57 Non - fatal MI 0 . 91 ( 0 . 73 1 . 14 ) 40 43 CHD death 1 . 01 ( 0 . 71 1 . 43 ) 16 16 All strokes 1.33 (1.05-1.68) 45 33 Ischemic stroke 1 . 55 ( 1 . 19 2 . 01 ) 38 25 Deep vein thrombosis , 1.47 (1.06 2.06) 23 15 Pulmonary embolism 1.37 (0.90 2.07) 14 10 Invasive breast cancer 0.80 (0.62 1.04) 28 34 Colorectal cancer 1.08 (0.75 1.55) 17 16 Hip fracture 0.65 (0.45 0.94) 12 19 Vertebral fractures , 0.64 (0.44-0.93) 11 18 Lower arm/wrist fractures , 0.58 (0.47-0.72) 35 59 Total fractures , 0.71 (0.64-0.80) 144 197 Death due to other causes , # 1.08 (0.88 1.32) 53 50 Overall mortality , 1.04 (0.88 1.22) 79 75 Global Index Þ 1.02 (0.92 1.13) 206 201 For those outcomes included in the WHI "global index" that reached statistical significance, the absolute excess risk per 10,000 women-years in the group treated with CE-alone was 12 more strokes, while the absolute risk reduction per 10,000 women-years was 7 fewer hip fracture. 9 The absolute excess risk of events included in the "global index" was a non-significant 5 events per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. No overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE-alone compared with placebo was reported in final centrally adjudicated results from the estrogen-alone substudy, after an average follow up of 7.1 years. Centrally adjudicated results for stroke events from the estrogen-alone substudy, after an average follow-up of 7.1 years, reported no significant difference in distribution of stroke subtype or severity, including fatal strokes, in women receiving CE-alone compared to placebo. Estrogen-alone increased the risk for ischemic stroke, and this excess risk was present in all subgroups of women examined. 10 Timing of the initiation of estrogen-alone therapy relative to the start of menopause may affect the overall risk benefit profile. The WHI estrogen-alone substudy, stratified by age, showed in women 50 to 59 years of age a non-significant trend toward reduced risk for CHD [HR 0.63 (95 percent CI, 0.36 to 1.09)] and overall mortality [HR 0.71 (95 percent CI, 0.46 to 1.11)]. Women s Health Initiative Memory Study The WHIMS estrogen plus progestin ancillary study of WHI enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age, 35 percent were 70 to 74 years of age, 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 cases per 10,000 women-years. Probable dementia as defined in this study included Alzheimer's disease (AD), vascular dementia (VaD) and mixed types (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see WARNINGS AND PRECAUTIONS ( 5.3 ), and USE IN SPECIFIC POPULATIONS ( 8.5 )]. The WHIMS estrogen-alone ancillary study of WHI study enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age (45 percent were 65 to 69 years of age, 36 percent were 70 to 74 years of age, 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg)-alone on the incidence of probable dementia (primary outcome) compared to placebo. After an average follow-up of 5.2 years, the relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years. Probable dementia as defined in this study included AD, VaD and mixed types (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see WARNINGS AND PRECAUTIONS ( 5.3 ), and USE IN SPECIFIC POPULATIONS ( 8.5 )]. When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women [see WARNINGS AND PRECAUTIONS ( 5.3 ), and USE IN SPECIFIC POPULATIONS ( 8.5 )]. REFERENCES 1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA . 2007;297:1465-1477. 2. Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med . 2006;166:357- 365. 3. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA . 2004;292:1573- 1580. 4. Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med . 2006;166:772-780. 5. Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA . 2003;289:3234-3253. 6. Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. JAMA . 2006;295:1647-1657. 7. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures. JAMA . 2003;290:1739-1748. 8. Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA . 2004;291:2947-2958. 9. Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women's Health Initiative Randomized Trial. J Bone Miner Res. 2006;21:817-828. 10. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women's Health Initiative. Circulation . 2006;113:2425-2434. How Supplied/Storage and Handling How Supplied Amabelz 1 mg/0.5 mg is a white to off-white, round shaped film-coated tablet debossed with "M54" on one side and "LU" on other side. Amabelz 1 mg/0.5 mg is available in a wallet (NDC 68180-830-11) containing 28 tablets enclosed in a pouch, such 3 pouches are packed in a carton (NDC 68180-830-13). Amabelz 0.5 mg/0.1 mg is a white to off-white, round shaped film-coated tablet debossed with "M53" on one side and "LU" on other side. Amabelz 0.5 mg/0.1 mg is available in a wallet (NDC 68180-829-11) containing 28 tablets enclosed in a pouch, such 3 pouches are packed in a carton (NDC 68180-829-13). Storage and Handling Store in a dry place protected from light. Store at 25 C (77 F), excursions permitted to 15 to 30 C (59 to 86 F). [See USP Controlled Room Temperature.] Patient Counseling Information See FDA-approved patient labeling (Patient Information) Abnormal Vaginal Bleeding Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.2 )]. Possible Serious Adverse Reactions with Estrogen Plus Progestin Therapy Inform postmenopausal women of possible serious adverse reactions of estrogen plus progestin therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 , 5.3 )]. Possible Less Serious but Common Adverse Reactions with Estrogen Plus Progestin Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen plus progestin therapy such as headache, breast pain and tenderness, nausea and vomiting. Rx only Amabelz is a trademark of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India May 2017 ID#: 251298 Amabelz (AM-ah-bells) (estradiol and norethindrone acetate tablets USP) Read this Patient Information before you start taking Amabelz and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. What is the most important information I should know about Amabelz (a combination of estrogen and progestin)? Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function). Taking estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Taking estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia. Taking estrogen-alone may increase your chance of getting cancer of the uterus (womb). Taking estrogen-alone may increase your chances of getting strokes or blood clots. Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older. You and your healthcare provider should talk regularly about whether you still need treatment with Amabelz. What is Amabelz? Amabelz is a prescription medicine that contains two kinds of hormones, an estrogen and a progestin. What is Amabelz used for? Amabelz is used after menopause to: reduce moderate to severe hot flushes Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 yrs old. This drop in body estrogen levels causes the "change of life" or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause." When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden, intense episodes of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether or not you still need treatment with Amabelz. treat moderate to severe menopausal changes in and around the vagina You and your healthcare provider should talk regularly about whether you still need treatment with Amabelz 1 mg/0.5 mg to treat these problems. If you use Amabelz 1 mg/0.5 mg only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. help reduce your chances of getting osteoporosis (thin weak bones) If you use Amabelz only to prevent osteoporosis from menopause, talk to your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Amabelz. Who should not take Amabelz? Do not take Amabelz if you have had your uterus (womb) removed (hysterectomy). Amabelz contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take Amabelz. Do not take Amabelz if you: have unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. currently have or have had certain cancers Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Amabelz. had a stroke or heart attack currently have or have had blood clots currently have or have had liver problems have been diagnosed with a bleeding disorder are allergic to Amabelz or any of its ingredients See the list of ingredients in Amabelz at the end of this leaflet. think you may be pregnant Amabelz is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take Amabelz if the test is positive and talk to your healthcare provider. What should I tell my healthcare provider before taking Amabelz? Before you take Amabelz, tell your healthcare provider if you: have any unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. have any other medical conditions Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. are going to have surgery or will be on bed rest Your healthcare provider will let you know if you need to stop taking Amabelz. are breast feeding The hormones in Amabelz can pass into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Amabelz works. Amabelz may also affect how your other medicines work. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine. How should I take Amabelz? Take Amabelz exactly as your healthcare provider tells you to take it. Take 1 Amabelz at the same time each day. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with Amabelz. Follow the instructions below to use your Amabelz Wallet Pack: 1. Set The Day Reminder Each wallet has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips of the week have been provided with this pack in order to accommodate beginning any day of the week. Pick the day label strip that starts with the current day of the week. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the wallet (Refer figure below). 2. How to take the first tablet. Remove tablet "1" by pushing down on the tablet. The tablet will come out through a hole in the back of the strip. The patient should wait 24 hours to take the next tablet. Moving across each row of the wallet, continue taking tablet daily until all tablets have been taken. When your wallet is empty, you will start a new wallet on the day after tablet "28." The first tablet in every refill will always be taken on the same day of the week, no matter when the patient takes the next tablet. What are the possible side effects of Amabelz? Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects include: heart attack stroke blood clots dementia breast cancer cancer of the lining of the uterus (womb) cancer of the ovary high blood pressure high blood sugar gallbladder disease liver problems changes in your thyroid hormone levels enlargement of benign tumors ("fibroids") Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: new breast lumps unusual vaginal bleeding changes in vision or speech sudden new severe headaches severe pains in your chest or legs with or without shortness of breath, weakness and fatigue Less serious, but common side effects include: headache breast pain irregular vaginal bleeding or spotting stomach or abdominal cramps, bloating nausea and vomiting hair loss fluid retention vaginal yeast infection These are not all the possible side effects of Amabelz. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or to FDA at 1-800-FDA-1088. What can I do to lower my chances of a serious side effect with Amabelz? Talk with your healthcare provider regularly about whether you should continue taking Amabelz. If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb). See your healthcare provider right away if you get vaginal bleeding while taking Amabelz. Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease. How should I store Amabelz? Store Amabelz at room temperature between 68 F to 77 F (20 C to 25 C). Store Amabelz in a dry place protected from light. KEEP Amabelz and all medicines out of the reach of children. General information about the safe and effective use of Amabelz. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Amabelz for conditions for which it was not prescribed. Do not give Amabelz to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about Amabelz. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about Amabelz that is written for health professionals. For more information, you can call our toll free number 1-800-399-2561 or you can visit the Lupin website at www.lupinpharmaceuticals.com. What are the ingredients in Amabelz? Active ingredients: estradiol and norethindrone acetate Inactive ingredients: copovidone, hypromellose, lactose monohydrate, magnesium stearate, starch (corn) and triacetin. Amabelz 1 mg/0.5 mg or Amabelz 0.5 mg/0.1 mg is supplied in a wallet pack enclosed in a pouch with the desiccants containing 28 tablets. This Patient Information has been approved by the U.S. Food and Drug Administration. Amabelz is a trademark of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India June 2016 ID: # 244731 Amabelz (estradiol and norethindrone acetate tablets USP) - 1 mg/0.5 mg Carton Pack: NDC: 681810-830-13 3 Pouches of 28 Tablets Each Rx only Amabelz (estradiol and norethindrone acetate tablets USP) - 1 mg/0.5 mg Pouch Pack: NDC: 681810-830-11 1 Wallet of 28 Tablets Rx only Pharmacist: Each unit contains information intended for the patients. See enclosed information for the patient including boxed warning. This informational piece is to be provided to the patient with each prescription. Amabelz (estradiol and norethindrone acetate tablets USP) - 1 mg/0.5 mg 28 Day Regimen Wallet Pack: NDC: 681810-830-11 28 Tablets Rx only Amabelz (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg Carton Pack: NDC: 681810-829-13 3 Pouches of 28 Tablets Each Rx only Amabelz (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg Pouch Pack: NDC: 681810-829-11 1 Wallet of 28 Tablets Rx only Pharmacist: Each unit contains information intended for the patients. See enclosed information for the patient including boxed warning. This informational piece is to be provided to the patient with each prescription. Amabelz (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg 28 Day Regimen Wallet Pack: NDC: 681810-829-11 28 Tablets Rx only Amabelz estradiol and norethindrone acetate tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68180-830 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.5 mg Inactive Ingredients Ingredient Name Strength COPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TRIACETIN Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code M54;LU Contains Packaging # Item Code Package Description 1 NDC:68180-830-13 3 POUCH in 1 CARTON 1 NDC:68180-830-11 1 BLISTER PACK in 1 POUCH 1 28 TABLET in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203339 10/21/2016 Amabelz estradiol and norethindrone acetate tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68180-829 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 0.5 mg NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.1 mg Inactive Ingredients Ingredient Name Strength COPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TRIACETIN Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code M53;LU Contains Packaging # Item Code Package Description 1 NDC:68180-829-13 3 POUCH in 1 CARTON 1 NDC:68180-829-11 1 BLISTER PACK in 1 POUCH 1 28 TABLET in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203339 10/21/2016 Labeler - Lupin Pharmaceuticals, Inc. (089153071) Registrant - LUPIN LIMITED (675923163) Establishment Name Address ID/FEI Operations LUPIN LIMITED 650582310 manufacture(68180-829, 68180-830), pack(68180-829, 68180-830) Revised: 05/2017 Lupin Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Amabelz (estradiol / norethindrone) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: sex hormone combinations Consumer resources Professional resources Other brands: Activella , Lopreeza , CombiPatch , Mimvey Related treatment guides Postmenopausal Symptoms> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Lupin Pharmaceuticals, Inc. Drug Class Sex hormone combinations Related Drugs sex hormone combinations Prempro , Lo Loestrin Fe , Estratest , Microgestin Fe 1 / 20 , Activella , Loestrin 24 Fe Postmenopausal Symptoms estradiol , Premarin , Estrace , Prempro , conjugated estrogens , Climara , Estrogel , Vivelle , Premarin Vaginal , Vivelle-Dot , Menest , Minivelle , Estratest , Delestrogen , Activella , Femring , Evamist , Lopreeza , CombiPatch , estradiol / norethindrone , Divigel , Mimvey , More... Amabelz Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } appears
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