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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Ninety-eight 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021574
Medical Subject Heading (MeSH) Categories for 021574
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)
Paragraph IV (Patent) Challenges for 021574
Tradename Dosage Ingredient NDA Submissiondate
FORTAMET TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021574 2008-10-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 27, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 17, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
Patent:  Start TrialPatent Expiration:Mar 17, 2021Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 27, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 17, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION

Expired US Patents for NDA 021574

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

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