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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
Harvard Business School

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201049

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NDA 201049 describes PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE profile page.

The generic ingredient in PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE is glimepiride; pioglitazone hydrochloride. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.
Summary for 201049
Ingredient:glimepiride; pioglitazone hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201049
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE glimepiride; pioglitazone hydrochloride TABLET;ORAL 201049 ANDA Sandoz Inc 0781-5634 0781-5634-31 30 TABLET in 1 BOTTLE (0781-5634-31)
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE glimepiride; pioglitazone hydrochloride TABLET;ORAL 201049 ANDA Sandoz Inc 0781-5634 0781-5634-10 1000 TABLET in 1 BOTTLE (0781-5634-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG;30MG
Approval Date:Jan 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG;30MG
Approval Date:Jan 4, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson

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