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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076801

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NDA 076801 describes PIOGLITAZONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Pharms Usa Inc, and Mylan, and is included in twenty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the PIOGLITAZONE HYDROCHLORIDE profile page.

The generic ingredient in PIOGLITAZONE HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 076801
Tradename:PIOGLITAZONE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:pioglitazone hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 076801
Suppliers and Packaging for NDA: 076801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 076801 ANDA Mylan Pharmaceuticals Inc. 0378-0048 N 0378-0048-05
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 076801 ANDA Mylan Pharmaceuticals Inc. 0378-0048 N 0378-0048-77

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No

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