Details for New Drug Application (NDA): 202456
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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 202456
Tradename: | PIOGLITAZONE HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | pioglitazone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202456
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 202456 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-306 | 68382-306-01 | 100 TABLET in 1 BOTTLE (68382-306-01) |
PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 202456 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-306 | 68382-306-05 | 500 TABLET in 1 BOTTLE (68382-306-05) |
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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