Details for New Drug Application (NDA): 200823

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NDA 200823 describes PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Norvium Bioscience, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in six NDAs. It is available from four 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-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

Tradename:	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	metformin hydrochloride; pioglitazone hydrochloride
Patents:	0

Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

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	200823	ANDA	AvKARE	42291-920	42291-920-90	90 TABLET, FILM COATED in 1 BOTTLE (42291-920-90)
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823	ANDA	AvKARE	42291-921	42291-921-90	90 TABLET, FILM COATED in 1 BOTTLE (42291-921-90)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG;EQ 15MG BASE
Approval Date:	Feb 13, 2013	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	850MG;EQ 15MG BASE
Approval Date:	Feb 13, 2013	TE:	AB	RLD:	No

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