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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079148

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NDA 079148 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 ninety-nine 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 five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 079148
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Indicus Pharma
Ingredient:metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 079148
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 079148
Suppliers and Packaging for NDA: 079148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 079148 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7626 0615-7626-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7626-39)
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 079148 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7626 0615-7626-31 31 TABLET, FILM COATED in 1 BLISTER PACK (0615-7626-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Nov 25, 2008TE:ABRLD:No

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Baxter
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