place of job [1%:<1% Injection:> <1% Cervical Cap with spermicides: 20 to 40% IUD:> <1 to 2% Condom alone (male): 14% Diaphragm with spermicides: 20% Condom alone (female): 21% Spermicides alone: 26% Periodic abstinence: 25% Vaginal sponge: 20 to 40% Withdrawal: 19% Female sterilization:> <1% No methods: 85%. WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions: A history of heart attack or stroke Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes A history of blood clots in the deep veins of your legs Chest pain (angina pectoris) Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina Unexplained vaginal bleeding (until a diagnosis is reached by your doctor) Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill Liver tumor (benign or cancerous) Hepatitis C and are taking any drug combination containing ombitasvir/partitaprevir/ritonavir, with or without dasabuvir, This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood. Known or suspected pregnancy. Tell your doctor or healthcare provider if you have ever had any of these conditions. Your doctor or healthcare provider can recommend another method of birth control. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your doctor or healthcare provider if you have: Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram Diabetes Elevated cholesterol or triglycerides High blood pressure Migraine or other headaches or epilepsy Mental depression Gallbladder, heart, or kidney disease History of scanty or irregular menstrual periods. Women with any of these conditions should be checked often by their doctor or healthcare provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or healthcare provider if you smoke or are on any medications. RISKS OF TAKING ORAL CONTRACEPTIVES 1. Risk of developing blood clots Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the leg can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel -containing oral contraceptives such as Simliya TM than with certain other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor or healthcare provider about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast-feeding or four weeks after a second trimester abortion. If you are breast-feeding, you should wait until you have weaned your child before using the pill (see Breast-Feeding in GENERAL PRECAUTIONS ) . The risk of circulatory disease in oral contraceptive users may be higher in users of high dose pills and may be greater with longer duration of oral contraceptive use. In addition, some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of venous thromboembolic disease associated with oral contraceptives does not increase with length of use and disappears after pill use is stopped. The risk of abnormal blood clotting increases with age in both users and non-users of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages. For women aged 20 to 44 it is estimated that about 1 in 2,000 using oral contraceptives will be hospitalized each year because of abnormal clotting. Among non-users in the same age group, about 1 in 20,000 would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34 the risk of death due to a circulatory disorder is about 1 in 12,000 per year, whereas for non-users the rate is about 1 in 50,000 per year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500 per year for oral contraceptive users and about 1 in 10,000 per year for non- users. 2. Heart attacks and strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. Gallbladder disease Oral contraceptive users probably have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. 4. Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in two studies, in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer. 5. Cancer of the reproductive organs and breasts There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table. ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NON-STERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE * Deaths are birth related ** Deaths are method related Method of control and outcome 15 to 19 20 to 24 25 to 29 30 to 34 35 to 39 40 to 44 No fertility control methods * 7 7.4 9.1 14.8 25.7 28.2 Oral contraceptives non-smoker ** 0.3 0.5 0.9 1.9 13.8 31.6 Oral contraceptives Smoker ** 2.2 3.4 6.6 13.5 51.1 117.2 IUD ** 0.8 0.8 1 1 1.4 1.4 Condom * 1.1 1.6 0.7 0.2 0.3 0.4 Diaphragm/spermicide * 1.9 1.2 1.2 1.3 2.2 2.8 Periodic abstinence * 2.5 1.6 1.6 1.7 2.9 3.6 In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older, high-dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective. WARNING SIGNALS If any of these adverse effects occur while you are taking oral contraceptives, call your doctor or healthcare provider immediately: Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung) Pain in the calf (indicating a possible clot in the leg) Crushing chest pain or heaviness in the chest (indicating a possible heart attack) Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke) Sudden partial or complete loss of vision (indicating a possible clot in the eye) Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or healthcare provider to show you how to examine your breasts) Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor) Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression) Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems). SIDE EFFECTS OF ORAL CONTRACEPTIVES 1. Vaginal bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or healthcare provider. 2. Contact lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or healthcare provider. 3. Fluid retention Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or healthcare provider. 4. Melasma A spotty darkening of the skin is possible, particularly of the face. 5. Other side effects Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects bother you, call your doctor or healthcare provider. GENERAL PRECAUTIONS 1. Missed periods and use of oral contraceptives before or during early pregnancy There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your doctor or healthcare provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant. Check with your doctor or healthcare provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these studies have not been confirmed. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor or healthcare provider. You should check with your doctor or healthcare provider about risks to your unborn child of any medication taken during pregnancy. 2. While breast-feeding If you are breast-feeding, consult your doctor or healthcare provider before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breast-feeding. You should use another method of contraception since breast-feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast-feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely. 3. Laboratory tests If you are scheduled for any laboratory tests, tell your doctor or healthcare provider you are taking birth control pills. Certain blood tests may be affected by birth control pills. 4. Drug interactions Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital), phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand), and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective. Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine. Some medicines may make birth control pill less effective, including: Barbiturates Bosentan Carbamazepine Felbamate Griseofulvin Oxcarbazepine Phenytoin Rifampin St. John s wort Topiramate As with all prescription products, you should notify your healthcare provider of any other medicines and herbal products you are taking. You may need to use a barrier contraceptive when you take drugs or products that can make birth control pills less effective. 5. Sexually transmitted diseases This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. HOW TO TAKE THE PILL IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING YOUR PILLS: 1. BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 TO 3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn t go away, check with your doctor or healthcare provider. 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or healthcare provider. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider about how to make pill-taking easier or about using another method of birth control. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or healthcare provider. BEFORE YOU START TAKING YOUR PILLS 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2. LOOK AT YOUR PILL PACK: IT WILL HAVE 28 PILLS: This 28-pill pack has 26 active [white to off-white and light blue] pills (with hormones) and 2 inactive [green] pills (without hormones). 3. ALSO FIND: 1) where on the pack to start taking the pills, 2) in what order to take the pills (follow the arrows) and 3) the week numbers as shown in the picture below. 4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam, or sponge) to use as a back-up in case you miss pills. AN EXTRA, FULL PILL PACK. WHEN TO START THE FIRST PACK OF PILLS You have a choice of which day to start taking your first pack of pills. Decide with your doctor or healthcare provider which is the best day for you. Pick a time of day which will be easy to remember. DAY 1 START 1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). 2. Place this day label strip on the blister pack over the area that has the days of the week (starting with Sunday) imprinted. Note: If the first day of your period is a Sunday, you can skip steps #1 and #2. 3. Take the first "active" [white to off-white] pill of the first pack during the first 24 hours of your period . 4. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period. SUNDAY START 1. Take the first active [white to off-white] pill of the first pack on the Sunday after your period starts , even if you are still bleeding. If your period begins on Sunday, start the pack that same day. 2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms, foam, or the sponge are good back-up methods of birth control. WHAT TO DO DURING THE MONTH 1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS: 21 pills : Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21-day packs. 28 pills : Start the next pack on the day after your last pill. Do not wait any days between packs. WHAT TO DO IF YOU MISS PILLS If you MISS 1 active [white to off-white] pill: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you take 2 pills in 1 day. 2. You do not need to use a back-up birth control method if you have sex. If you MISS 2 active [white to off-white] pills in a row in WEEK 1 OR WEEK 2 of your pack: 1. Take 2 pills on the day you remember and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back- up method for those 7 days. If you MISS 2 active [white to off-white] pills in a row in WEEK 3: 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or healthcare provider because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days. If you MISS 3 OR MORE active [white to off-white] pills in a row (during the first 3 weeks): 1. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or healthcare provider because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days. A REMINDER FOR THOSE ON 28-DAY PACKS If you forget any of the 2 [green] or 5 [light blue] pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE ACTIVE [WHITE TO OFF-WHITE] PILL EACH DAY until you can reach your doctor or healthcare provider. PREGNANCY DUE TO PILL FAILURE The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 5%. If failure does occur, the risk to the fetus is minimal. PREGNANCY AFTER STOPPING THE PILL There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your doctor, healthcare provider or pharmacist. OTHER INFORMATION Your doctor or healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and your doctor or the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your doctor or healthcare provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your doctor or healthcare provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. HEALTH BENEFITS FROM ORAL CONTRACEPTIVES In addition to preventing pregnancy, use of combination oral contraceptives may provide certain benefits. They are: menstrual cycles may become more regular. blood flow during menstruation may be lighter and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur. pain or other symptoms during menstruation may be encountered less frequently. ectopic (tubal) pregnancy may occur less frequently. non-cancerous cysts or lumps in the breast may occur less frequently. acute pelvic inflammatory disease may occur less frequently. oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus. If you want more information about birth control pills, ask your doctor, healthcare provider, or pharmacist. They have a more technical leaflet called the Prescribing Information which you may wish to read. The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Revised: 08/2017 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.15 mg/0.02 mg and 0.01 mg (Pouch Label) 28 Day Regimen NDC 65862-886-28 Simliya TM (desogestrel and ethinyl e stradiol tablets, USP and ethinyl estradiol t ablets, USP) 0.15 mg/0.02 mg and 0.01 mg This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Rx only 1 Pouch of 28 Tablets AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.15 mg/0.02 mg and 0.01 mg (Pouch Carton) 28 Day Regimen NDC 65862-886-92 Simliya TM (desogestrel and ethinyl e stradiol tablets, USP and ethinyl estradiol t ablets, USP) 0.15 mg/0.02 mg and 0.01 mg Rx only 6 Pouches of 28 Tablets Each Simliya desogestrel and ethinyl estradiol and ethinyl estradiol kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-886 Packaging # Item Code Package Description 1 NDC:65862-886-92 6 POUCH in 1 CARTON 1 NDC:65862-886-28 1 BLISTER PACK in 1 POUCH 1 1 KIT in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 21 Part 2 2 Part 3 5 Part 1 of 3 Simliya desogestrel and ethinyl estradiol tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE LACTOSE MONOHYDRATE STARCH, POTATO POVIDONE K30 STEARIC ACID .ALPHA.-TOCOPHEROL, DL- Product Characteristics Color WHITE (White to off-White) Score no score Shape ROUND (biconvex) Size 6mm Flavor Imprint Code S;51 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206853 03/22/2017 Part 2 of 3 INERT inert tablet Product Information Route of Administration ORAL DEA Schedule Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FERRIC OXIDE YELLOW MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30 Product Characteristics Color GREEN Score no score Shape ROUND (mottled biconvex) Size 6mm Flavor Imprint Code S;61 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206853 03/22/2017 Part 3 of 3 Simliya ethinyl estradiol tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.01 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE FD&C BLUE NO. 1 LACTOSE MONOHYDRATE POVIDONE K30 STARCH, CORN STEARIC ACID .ALPHA.-TOCOPHEROL, DL- Product Characteristics Color BLUE (Light Blue) Score no score Shape ROUND (mottled biconvex) Size 6mm Flavor Imprint Code S;45 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206853 03/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206853 03/22/2017 Labeler - Aurobindo Pharma Limited (650082092) Establishment Name Address ID/FEI Operations Aurobindo Pharma Limited 650381903 ANALYSIS(65862-886), MANUFACTURE(65862-886) Revised: 08/2017 Aurobindo Pharma Limited Next Interactions Print this page Add to My Med List More about Simliya (desogestrel / ethinyl estradiol) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: contraceptives Consumer resources Professional resources Desogestrel and Ethinyl Estradiol (FDA) Other brands: Apri , Azurette , Reclipsen , Viorele , ... +18 more Related treatment guides Birth Control> ]} 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 Manufacturer Aurobindo Pharma Limited Drug Class Contraceptives Related Drugs contraceptives medroxyprogesterone , Provera , Depo-Provera , norethindrone , Mirena , Nexplanon Birth Control medroxyprogesterone , Provera , Depo-Provera , norethindrone , Mirena , Nexplanon , Sprintec , levonorgestrel , NuvaRing , Ortho Tri-Cyclen , Yasmin , Yaz , TriNessa , Aviane , Lo Loestrin Fe , Apri , Alesse , Mononessa , Microgestin Fe 1 / 20 , Camila , Xulane , Seasonique , Lutera , Ortho Evra , Levora , More... 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