Details for New Drug Application (NDA): 078670
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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 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078670
Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No |
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