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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077113

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NDA 077113 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 Labs 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-three NDAs. It is available from one hundred and three 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 and nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 077113
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Mylan
Ingredient:metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077113

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Sep 8, 2005TE:RLD:No

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