Details for New Drug Application (NDA): 076345
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NDA 076345 describes GLYBURIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms, and is included in seven NDAs. It is available from twelve suppliers. Additional details are available on the GLYBURIDE AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 076345
| Tradename: | GLYBURIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Impax Labs Inc |
| Ingredient: | glyburide; metformin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;250MG | ||||
| Approval Date: | Feb 18, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Feb 18, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Feb 18, 2004 | TE: | AB | RLD: | No | ||||
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