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Serving leading biopharmaceutical companies globally:

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Generated: January 20, 2018

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 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 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-two NDAs. It is available from one hundred 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 six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 201991
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Inventia Hlthcare
Ingredient:metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 201991
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 201991
Suppliers and Packaging for NDA: 201991
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE 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 metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 201991 ANDA Blenheim Pharmacal, Inc. 10544-944 10544-944-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-944-90)

Profile for product number 001

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

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