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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 202522

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NDA 202522 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 202522

Tradename:	FOLIC ACID
Applicant:	Xgen Pharms
Ingredient:	folic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 202522

Hematinics
Vitamin B Complex

Suppliers and Packaging for NDA: 202522

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOLIC ACID	folic acid	INJECTABLE;INJECTION	202522	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-1100	39822-1100-1	1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	Nov 6, 2019	TE:	AP	RLD:	No

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