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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 204418

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NDA 204418 describes FOLIC ACID, which is a drug marketed by Ben Venue, Fresenius Kabi Usa, Xgen Pharms, Amneal Pharm, Athem, Barr, Cadila Pharms Ltd, Chartwell Molecular, Contract Pharmacal, Endo Operations, Everylife, Halsey, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Lannett, Leading, Lilly, Mk Labs, Nexgen Pharma Inc, Nuvo Pharms Inc, Pharmeral, Pioneer Pharms, Purepac Pharm, Qingdao Baheal Pharm, 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-nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the folic acid profile page.

Summary for 204418

Tradename:	FOLIC ACID
Applicant:	Nuvo Pharms Inc
Ingredient:	folic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 204418

Hematinics
Vitamin B Complex

Suppliers and Packaging for NDA: 204418

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOLIC ACID	folic acid	TABLET;ORAL	204418	ANDA	SUNRISE PHARMACEUTICAL, INC.	11534-165	11534-165-01	100 TABLET in 1 BOTTLE (11534-165-01)
FOLIC ACID	folic acid	TABLET;ORAL	204418	ANDA	SUNRISE PHARMACEUTICAL, INC.	11534-165	11534-165-03	1000 TABLET in 1 BOTTLE (11534-165-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 28, 2015	TE:	AA	RLD:	No

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