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Covington
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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076801

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NDA 076801 describes PIOGLITAZONE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Teva Pharms Usa, Lupin Ltd, Puracap Pharm Llc, Accord Hlthcare, Zydus Pharms Usa Inc, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Sandoz, Breckenridge Pharm, Dr Reddys Labs Ltd, Cipla Ltd, Torrent Pharms Ltd, 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 076801

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

Pharmacology for NDA: 076801

Suppliers and Packaging for NDA: 076801

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL 076801 ANDA Mylan Pharmaceuticals Inc. 0378-0048 0378-0048-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-0048-05)
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL 076801 ANDA Mylan Pharmaceuticals Inc. 0378-0048 0378-0048-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-0048-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Aug 17, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
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Colorcon
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Healthtrust
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