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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201991

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NDA 201991 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Apotex, Intellipharmaceutics, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharms Ltd, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, 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-seven 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-three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 201991

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

Pharmacology for NDA: 201991


Suppliers and Packaging for NDA: 201991

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 201991 ANDA Sandoz Inc. 0781-5503 0781-5503-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5503-01)
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 201991 ANDA Blenheim Pharmacal, Inc. 10544-944 10544-944-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-944-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 18, 2012TE:AB1RLD:No

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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
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Federal Trade Commission
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