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FDA Approval

Concept DHA

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

FDA Approval Summary

Company
U.S. Pharmaceutical Corporation
DUNS: 079467662
Effective Date
November 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Thiamine(2 mg in 1 1)
Ferrous fumarate(17.5 mg in 1 1)
Iron(17.5 mg in 1 1)
Vitamin C(25 mg in 1 1)
Folic acid(1 mg in 1 1)
Vitamin B12(12.5 ug in 1 1)
Riboflavin(3 mg in 1 1)
Niacin(1.8 mg in 1 1)
Pantothenic acid(5 mg in 1 1)
Pyridoxine(25 mg in 1 1)
Biotin(300 ug in 1 1)
Cupric sulfate(2 mg in 1 1)

Products1

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

Concept DHA

Product Details

NDC Product Code
52747-621
Route of Administration
ORAL
Effective Date
July 13, 2022
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 2 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 17.5 mg in 1 1
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 17.5 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 25 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 12.5 ug in 1 1
Code: 89DS0H96TBClass: ACTIMQuantity: 10 mg in 1 1
Code: D87YGH4Z0QClass: ACTIBQuantity: 200 mg in 1 1
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Code: TLM2976OFRClass: ACTIBQuantity: 3 mg in 1 1
NiacinActive
Code: 2679MF687AClass: ACTIBQuantity: 1.8 mg in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 5 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 25 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
Code: LRX7AJ16DTClass: ACTIMQuantity: 2 mg in 1 1
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
Code: DE08037SABClass: ACTIBQuantity: 5 mg in 1 1
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