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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076172

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NDA 076172 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi Pharm Co, Impax Labs, Intellipharmaceutics, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, and Zydus Hlthcare, and is included in seventy-two NDAs. It is available from ninety-four suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE 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 076172

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 076172

Ingredient-typeBiguanides

Medical Subject Heading (MeSH) Categories for 076172

Suppliers and Packaging for NDA: 076172

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076172 ANDA Blenheim Pharmacal, Inc. 10544-248 10544-248-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10544-248-30)
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076172 ANDA Blenheim Pharmacal, Inc. 10544-248 10544-248-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10544-248-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jun 16, 2004TE:AB1RLD:No


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