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Details for New Drug Application (NDA): 091155

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NDA 091155 describes PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Torrent Pharms Ltd, Macleods Pharms Ltd, Mylan, Aurobindo Pharma Ltd, Teva Pharms Usa, and Sandoz, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-seven 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 NDA: 091155

Suppliers and Packaging for NDA: 091155

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL 091155 ANDA Teva Pharmaceuticals USA Inc 0093-7677 0093-7677-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-7677-06)
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL 091155 ANDA Teva Pharmaceuticals USA Inc 0093-7677 0093-7677-86 180 TABLET, FILM COATED in 1 BOTTLE (0093-7677-86)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 15MG BASE
Approval Date:Mar 10, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG;EQ 15MG BASE
Approval Date:Mar 10, 2014TE:ABRLD:No


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