PRENATE DHA
DHA
Approved
Approval ID
8f2eca71-9a82-4a19-9206-36a04b865fe1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
Avion Pharmaceuticals, LLC
DUNS: 040348516
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent
PRODUCT DETAILS
NDC Product Code75854-312
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 7, 2021
Generic Nameascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent
INGREDIENTS (19)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ASCORBIC ACIDActive
Quantity: 90 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 26 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 25 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM FORMATEActive
Quantity: 155 mg in 1 1
Code: NP3JD65NPY
Classification: ACTIM
FERROUS ASPARTO GLYCINATEActive
Quantity: 18 mg in 1 1
Code: H7426RGB3L
Classification: ACTIM
MAGNESIUM OXIDEActive
Quantity: 50 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIM
DOCONEXENTActive
Quantity: 300 mg in 1 1
Code: ZAD9OKH9JC
Classification: ACTIB
.ALPHA.-TOCOPHEROL, DL-Active
Quantity: 40 [iU] in 1 1
Code: 7QWA1RIO01
Classification: ACTIB