Details for New Drug Application (NDA): 021574

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NDA 021574 describes FORTAMET, which is a drug marketed by Andrx Labs Llc and is included in one NDA. It is available from one supplier. Additional details are available on the FORTAMET profile page.

The generic ingredient in FORTAMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 021574

Tradename:	FORTAMET
Applicant:	Andrx Labs Llc
Ingredient:	metformin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 021574

Hypoglycemic Agents

Suppliers and Packaging for NDA: 021574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2719	0591-2719-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2719-60)
FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2720	0591-2720-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2720-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 27, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 27, 2004	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 021574

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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