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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Healthtrust
McKesson
Baxter
Cantor Fitzgerald
Moodys
Medtronic
Cerilliant
AstraZeneca

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200268

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NDA 200268 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 200268

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

Pharmacology for NDA: 200268

Suppliers and Packaging for NDA: 200268

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 200268 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-326 43353-326-30 30 TABLET in 1 BOTTLE (43353-326-30)
PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 200268 ANDA LUCID PHARMA LLC 52343-053 52343-053-05 500 TABLET in 1 BOTTLE (52343-053-05)

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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Serving leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
McKinsey
Merck
Medtronic
McKesson
US Army
Deloitte
Johnson and Johnson
AstraZeneca

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