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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 077711


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NDA 077711 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Saptalis Pharms, Vistapharm, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Amta, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Glenmark Generics, Granules India, Harman Finochem, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, and Dr Reddys Labs Sa, and is included in one hundred NDAs. It is available from eighty-three suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 077711
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Torrent Pharms
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077711

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Jan 24, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength850MG
Approval Date:Jan 24, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1GM
Approval Date:Jan 24, 2007TE:RLD:No

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