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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075967

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NDA 075967 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-eight 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. Ninety-four suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 075967

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 075967

Ingredient-typeBiguanides

Suppliers and Packaging for NDA: 075967

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL 075967 ANDA Rebel Distributors Corp. 21695-471 21695-471-00 100 TABLET in 1 BOTTLE (21695-471-00)
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL 075967 ANDA Rebel Distributors Corp. 21695-471 21695-471-30 30 TABLET in 1 BOTTLE (21695-471-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 29, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Jan 29, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jan 29, 2002TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Deloitte
Dow
Citi
McKesson
Cantor Fitzgerald
Novartis
Julphar
Teva
Express Scripts
Johnson and Johnson

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