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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078670

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NDA 078670 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, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Pharms Usa Inc, and Mylan, and is included in twenty NDAs. It is available from twenty-four 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. Thirteen suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

Summary for 078670

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

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 0781-5420-64 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0781-5420-64) > 1 TABLET in 1 BLISTER PACK (0781-5420-06)
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078670 ANDA Sandoz Inc 0781-5420 0781-5420-31 30 TABLET in 1 BOTTLE (0781-5420-31)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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