Last Updated: May 11, 2026

Details for New Drug Application (NDA): 040625

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NDA 040625 describes FOLIC ACID, which is a drug marketed by Ben Venue, Fresenius Kabi Usa, Xgen Pharms, Aiping Pharm Inc, Amneal Pharm, Barr, Cadila Pharms Ltd, Chartwell Molecular, Contract Pharmacal, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Lannett, Leading, Lilly, Mk Labs, Nexgen Pharma Inc, Nuvo Pharms Inc, Ph Health, Pharmeral, Pioneer Pharms, Purepac Pharm, Rising, Sandoz, Sun Pharm Industries, Tablicaps, UDL, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-eight NDAs. It is available from twenty-eight suppliers. Additional details are available on the FOLIC ACID profile page.

The generic ingredient in FOLIC ACID is folic acid. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the folic acid profile page.

Summary for 040625

Tradename:	FOLIC ACID
Applicant:	Amneal Pharm
Ingredient:	folic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 040625

Hematinics
Vitamin B Complex

Suppliers and Packaging for NDA: 040625

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOLIC ACID	folic acid	TABLET;ORAL	040625	ANDA	Major Pharmaceuticals	0904-7224	0904-7224-61	100 BLISTER PACK in 1 CARTON (0904-7224-61) / 1 TABLET in 1 BLISTER PACK
FOLIC ACID	folic acid	TABLET;ORAL	040625	ANDA	Amneal Pharmaceuticals of New York LLC	53746-361	53746-361-01	100 TABLET in 1 BOTTLE (53746-361-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 21, 2005	TE:	AA	RLD:	No

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