Details for New Drug Application (NDA): 201049
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NDA 201049 describes PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, which is a drug marketed by Chartwell Rx and is included in one NDA. 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. Two 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. Two 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: | Chartwell Rx |
| Ingredient: | glimepiride; pioglitazone hydrochloride |
| Patents: | 0 |
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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