bsp;INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Fish oil (UNII: XGF7L72M0F) (Fish oil - UNII:XGF7L72M0F) Fish oil 0.1 g in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
.alpha.-tocopherol, dl- (UNII: 7QWA1RIO01)
egg phospholipids (UNII: 1Z74184RGV)
sodium oleate (UNII: 399SL044HN)
glycerin (UNII: PDC6A3C0OX)
sodium hydroxide (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63323-205-50 10 in 1 CARTON 07/27/2018
1 NDC:63323-205-21 50 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2 NDC:63323-205-00 10 in 1 CARTON 07/27/2018
2 NDC:63323-205-31 100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210589 07/27/2018
LABELER - FRESENIUS KABI USA, LLC (608775388)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Fresenius Kabi Austria 300206604 MANUFACTURE(63323-205)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d9d0b24-e139-48bf-ab2d-536fb59cf8e0 |
