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Folic Acid

FOLIC ACID TABLETS, USP

Approved
Approval ID

bf7a068c-8b1e-2d7a-e053-2995a90a417a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 8, 2021

Manufacturers
FDA

ECI PHARMACEUTICALS LLC

DUNS: 962476029

Products 1

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

Folic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51293-846
Application NumberANDA091145
Product Classification
M
Marketing Category
C73584
G
Generic Name
Folic Acid
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2021
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Folic Acid - FDA Drug Approval Details