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Generated: December 11, 2017

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 four suppliers. There are six 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-eight drug master file entries for this compound. One hundred suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 021574

Tradename:1
Applicant:1
Ingredient:1
Patents:6
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021574

Ingredient-typeBiguanides

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 27, 2004TE:AB2RLD:Yes
Patent:► SubscribePatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 17, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION


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