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FDA Approval

Chromagen

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

FDA Approval Summary

Company
Effective Date
January 23, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ferrous fumarate(50 mg in 1 1)
Vitamin C(60 mg in 1 1)
Levomefolic acid(750 ug in 1 1)
Folic acid(250 ug in 1 1)
Vitamin B12(10 ug in 1 1)
Zinc(12 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Avion Pharmaceuticals, LLC

Avion Pharmaceuticals, LLC

040348516

Products1

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

Chromagen

Product Details

NDC Product Code
75854-320
Route of Administration
ORAL
Effective Date
January 18, 2021
WATERInactive
Code: 059QF0KO0RClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
GELATIN TYPE B BOVINE (200 BLOOM)Inactive
Code: A7JR5F8DLHClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
CAROBInactive
Code: 5MG5Z946UOClass: IACT
CARAMELInactive
Code: T9D99G2B1RClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
Code: H7426RGB3LClass: ACTIMQuantity: 25 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 50 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1
Code: 8S95DH25XCClass: ACTIBQuantity: 750 ug in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 250 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 10 ug in 1 1
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 12 mg in 1 1
Code: 70BT6OQT2QClass: ACTIBQuantity: 100 mg in 1 1
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