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 sixteen 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.
The generic ingredient in PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE is glimepiride; pioglitazone hydrochloride. There are sixteen 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
| Tradename: | PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE |
| Applicant: | Sandoz |
| Ingredient: | glimepiride; pioglitazone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 201049
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
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 | 0781-5634-10 | 1000 TABLET in 1 BOTTLE (0781-5634-10) |
| 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) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG;30MG | ||||
| Approval Date: | Jan 4, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG;30MG | ||||
| Approval Date: | Jan 4, 2013 | TE: | AB | RLD: | No | ||||
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