Details for New Drug Application (NDA): 079009
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NDA 079009 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 eleven 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 079009
| Tradename: | GLYBURIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Heritage |
| Ingredient: | glyburide; metformin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079009
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 079009 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-233 | 23155-233-01 | 100 TABLET in 1 BOTTLE (23155-233-01) |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 079009 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-233 | 23155-233-05 | 500 TABLET in 1 BOTTLE (23155-233-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;250MG | ||||
| Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No | ||||
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