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Generated: April 28, 2017

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Details for New Drug Application (NDA): 203686

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NDA 203686 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Apotex, Intellipharmaceutics, 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, Beximco Pharms Usa, Teva, Atlas Pharms Llc, Sun Pharm Inds (in), Ivax Sub Teva Pharms, Indicus Pharma, Impax Labs, Actavis Elizabeth, Provident Pharm, Actavis Labs Fl Inc, Macleods Pharms Ltd, 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 seventy-one NDAs. It is available from eighty-eight suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-seven drug master file entries for this compound. Ninety-four 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: 203686

Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 203686


Suppliers and Packaging for NDA: 203686

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metformin hydrochloride
TABLET;ORAL 203686 ANDA Blenheim Pharmacal, Inc. 10544-957 10544-957-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-957-90)
metformin hydrochloride
TABLET;ORAL 203686 ANDA Cardinal Health 55154-4675 55154-4675-0 10 BLISTER PACK in 1 BAG (55154-4675-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 28, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Aug 28, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Aug 28, 2014TE:ABRLD:No

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