significant BEL Item Code (Source) NDC:0338-9540 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLIVE OIL (OLIVE OIL) OLIVE OIL 16 g in 100 mL SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength EGG PHOSPHOLIPIDS 1.20 g in 100 mL GLYCERIN 2.25 g in 100 mL SODIUM OLEATE 0.03 g in 100 mL Packaging # Item Code Package Description 1 NDC:0338-9540-08 6 BAG in 1 CARTON 1 NDC:0338-9540-04 1000 mL in 1 BAG 2 NDC:0338-9540-07 12 BAG in 1 CARTON 2 NDC:0338-9540-03 500 mL in 1 BAG 3 NDC:0338-9540-06 10 BAG in 1 CARTON 3 NDC:0338-9540-02 250 mL in 1 BAG 4 NDC:0338-9540-05 15 BAG in 1 CARTON 4 NDC:0338-9540-01 100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204508 01/01/2016 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Operations Baxter SA 370353835 MANUFACTURE(0338-9540) is normally

significant BEL Item Code (Source) NDC:0338-9540 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLIVE OIL (OLIVE OIL) OLIVE OIL 16 g in 100 mL SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength EGG PHOSPHOLIPIDS 1.20 g in 100 mL GLYCERIN 2.25 g in 100 mL SODIUM OLEATE 0.03 g in 100 mL Packaging # Item Code Package Description 1 NDC:0338-9540-08 6 BAG in 1 CARTON 1 NDC:0338-9540-04 1000 mL in 1 BAG 2 NDC:0338-9540-07 12 BAG in 1 CARTON 2 NDC:0338-9540-03 500 mL in 1 BAG 3 NDC:0338-9540-06 10 BAG in 1 CARTON 3 NDC:0338-9540-02 250 mL in 1 BAG 4 NDC:0338-9540-05 15 BAG in 1 CARTON 4 NDC:0338-9540-01 100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204508 01/01/2016 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Operations Baxter SA 370353835 MANUFACTURE(0338-9540) is normally

October 24, 2015
to surround BEL Item Code (Source) NDC:0338-9540 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLIVE OIL (OLIVE OIL) OLIVE OIL 16 g in 100 mL SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength EGG PHOSPHOLIPIDS 1.20 g in 100 mL GLYCERIN 2.25 g in 100 mL SODIUM OLEATE 0.03 g in 100 mL Packaging # Item Code Package Description 1 NDC:0338-9540-08 6 BAG in 1 CARTON 1 NDC:0338-9540-04 1000 mL in 1 BAG 2 NDC:0338-9540-07 12 BAG in 1 CARTON 2 NDC:0338-9540-03 500 mL in 1 BAG 3 NDC:0338-9540-06 10 BAG in 1 CARTON 3 NDC:0338-9540-02 250 mL in 1 BAG 4 NDC:0338-9540-05 15 BAG in 1 CARTON 4 NDC:0338-9540-01 100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204508 01/01/2016 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Operations Baxter SA 370353835 MANUFACTURE(0338-9540) often
 
Photo :BEL Item Code (Source) NDC:0338-9540 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLIVE OIL (OLIVE OIL) OLIVE OIL 16 g in 100 mL SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength EGG PHOSPHOLIPIDS 1.20 g in 100 mL GLYCERIN 2.25 g in 100 mL SODIUM OLEATE 0.03 g in 100 mL Packaging # Item Code Package Description 1 NDC:0338-9540-08 6 BAG in 1 CARTON 1 NDC:0338-9540-04 1000 mL in 1 BAG 2 NDC:0338-9540-07 12 BAG in 1 CARTON 2 NDC:0338-9540-03 500 mL in 1 BAG 3 NDC:0338-9540-06 10 BAG in 1 CARTON 3 NDC:0338-9540-02 250 mL in 1 BAG 4 NDC:0338-9540-05 15 BAG in 1 CARTON 4 NDC:0338-9540-01 100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204508 01/01/2016 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Operations Baxter SA 370353835 MANUFACTURE(0338-9540)

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prescription drugs BEL Item Code (Source) NDC:0338-9540 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLIVE OIL (OLIVE OIL) OLIVE OIL 16 g in 100 mL SOYBEAN OIL (SOYBEAN OIL) SOYBEAN OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength EGG PHOSPHOLIPIDS 1.20 g in 100 mL GLYCERIN 2.25 g in 100 mL SODIUM OLEATE 0.03 g in 100 mL Packaging # Item Code Package Description 1 NDC:0338-9540-08 6 BAG in 1 CARTON 1 NDC:0338-9540-04 1000 mL in 1 BAG 2 NDC:0338-9540-07 12 BAG in 1 CARTON 2 NDC:0338-9540-03 500 mL in 1 BAG 3 NDC:0338-9540-06 10 BAG in 1 CARTON 3 NDC:0338-9540-02 250 mL in 1 BAG 4 NDC:0338-9540-05 15 BAG in 1 CARTON 4 NDC:0338-9540-01 100 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA204508 01/01/2016 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Operations Baxter SA 370353835 MANUFACTURE(0338-9540) conflict


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