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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 084158

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NDA 084158 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 084158

Tradename:	FOLIC ACID
Applicant:	Pharmeral
Ingredient:	folic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 084158

Hematinics
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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