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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077210

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NDA 077210 describes PIOGLITAZONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, 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. Eleven suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 077210
Tradename:PIOGLITAZONE HYDROCHLORIDE
Applicant:Teva Pharms Usa
Ingredient:pioglitazone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077210
Suppliers and Packaging for NDA: 077210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 077210 ANDA Teva Pharmaceuticals USA, Inc. 0093-7271 0093-7271-05 500 TABLET in 1 BOTTLE (0093-7271-05)
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 077210 ANDA Teva Pharmaceuticals USA, Inc. 0093-7271 0093-7271-56 30 TABLET in 1 BOTTLE (0093-7271-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jan 10, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jan 10, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Jan 10, 2014TE:ABRLD:No

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