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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078670


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NDA 078670 describes PIOGLITAZONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Labs Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from twenty-six 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-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.
Summary for 078670
Tradename:PIOGLITAZONE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:pioglitazone hydrochloride
Patents:0
Pharmacology for NDA: 078670
Suppliers and Packaging for NDA: 078670
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078670 ANDA Sandoz Inc 0781-5420 0781-5420-10 1000 TABLET in 1 BOTTLE (0781-5420-10)
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078670 ANDA Sandoz Inc 0781-5420 0781-5420-31 30 TABLET in 1 BOTTLE (0781-5420-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Feb 13, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Feb 13, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Feb 13, 2013TE:ABRLD:No

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