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Details for New Drug Application (NDA): 078422

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NDA 078422 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Apotex, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharm, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, Torrent Pharms Ltd, Teva, Atlas Pharms Llc, Sun Pharm Inds (in), Ivax Sub Teva Pharms, Indicus Pharma, Impax Labs, Actavis Elizabeth, Provident Pharm, Actavis Labs Fl Inc, Nostrum Pharms Llc, Zydus Pharms Usa, Watson Labs Florida, Barr, Lupin Ltd, Granules India, Sun Pharm Inds Inc, Mylan Pharms Inc, Sciegen Pharms Inc, Glenmark Generics, Chartwell Life Sci, Watson Labs, Amneal Pharms Ny, Alkem, Zydus Hlthcare, Dr Reddys Labs Inc, Marksans Pharma, Inventia Hlthcare, and Aurobindo, and is included in sixty-eight NDAs. It is available from seventy-nine suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-six drug master file entries for this compound. Eighty-five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 078422

Ipca Labs Ltd
metformin hydrochloride
Therapeutic Class:Blood Glucose Regulators

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Aug 6, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength850MG
Approval Date:Aug 6, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1GM
Approval Date:Aug 6, 2007TE:RLD:No

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