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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
MATERNAL SCIENCE, LLC
DUNS: 078722406
Effective Date
July 9, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
.beta.-carotene(4000 [iU] in 1 1)
Vitamin C(120 mg in 1 1)
Vitamin D3(400 [iU] in 1 1)
Thiamine(1.8 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Niacin(20 mg in 1 1)
Pyridoxine(2.6 mg in 1 1)
Folic acid(800 ug in 1 1)
Mecobalamin(8 ug in 1 1)
Calcium carbonate(200 mg in 1 1)
Ferrous bisglycinate(28 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Copper(2 mg in 1 1)
Biotin(30 ug in 1 1)
Pantothenic acid(10 mg in 1 1)
Magnesium oxide(30 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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Product Details

NDC Product Code
58154-107
Route of Administration
ORAL
Effective Date
July 9, 2013
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
.beta.-caroteneActive
Code: 01YAE03M7JClass: ACTIBQuantity: 4000 [iU] in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 1.8 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
NiacinActive
Code: 2679MF687AClass: ACTIBQuantity: 20 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 2.6 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 800 ug in 1 1
Code: BR1SN1JS2WClass: ACTIBQuantity: 8 ug in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 200 mg in 1 1
Code: SFW1D987QVClass: ACTIMQuantity: 28 mg in 1 1
Code: SOI2LOH54ZClass: ACTIMQuantity: 25 mg in 1 1
CopperActive
Code: 789U1901C5Class: ACTIBQuantity: 2 mg in 1 1
ASCORBYL PALMITATEInactive
Code: QN83US2B0NClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YIClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 30 ug in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Code: 3A3U0GI71GClass: ACTIBQuantity: 30 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 30 [iU] in 1 1
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