Details for New Drug Application (NDA): 206748
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NDA 206748 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 206748
| Tradename: | GLYBURIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | glyburide; metformin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206748
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 206748 | ANDA | Zydus Lifesciences Limited | 65841-824 | 65841-824-01 | 100 TABLET in 1 BOTTLE (65841-824-01) |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 206748 | ANDA | Zydus Lifesciences Limited | 65841-824 | 65841-824-05 | 500 TABLET in 1 BOTTLE (65841-824-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;250MG | ||||
| Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No | ||||
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