Details for New Drug Application (NDA): 206749
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NDA 206749 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Natco Pharma, Sanofi Aventis Us, and Strides Pharma, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the GLYBURIDE profile page.
The generic ingredient in GLYBURIDE 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 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 206749
| Tradename: | GLYBURIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | glyburide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206749
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE | glyburide | TABLET;ORAL | 206749 | ANDA | Zydus Lifesciences Limited | 65841-832 | 65841-832-01 | 100 TABLET in 1 BOTTLE (65841-832-01) |
| GLYBURIDE | glyburide | TABLET;ORAL | 206749 | ANDA | Zydus Lifesciences Limited | 65841-832 | 65841-832-05 | 500 TABLET in 1 BOTTLE (65841-832-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
| Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No | ||||
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