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Serving leading biopharmaceutical companies globally:

Harvard Business School
Covington
Queensland Health
Boehringer Ingelheim
Mallinckrodt
Dow
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Moodys
Chinese Patent Office
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090295

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NDA 090295 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 090295
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Marksans Pharma
Ingredient:metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 090295
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 090295
Suppliers and Packaging for NDA: 090295
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090295 ANDA MARKSANS PHARMA LIMITED 25000-101 25000-101-98 1 BAG in 1 BOX (25000-101-98) > 11695 TABLET, EXTENDED RELEASE in 1 BAG
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090295 ANDA MARKSANS PHARMA LIMITED 25000-101 25000-101-12 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 29, 2016TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 29, 2016TE:ABRLD:No

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Accenture
Medtronic
Johnson and Johnson
Merck
Farmers Insurance
Argus Health
US Department of Justice
Novartis
Mallinckrodt

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