Details for New Drug Application (NDA): 203379
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NDA 203379 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 eighteen 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 203379
| Tradename: | GLYBURIDE |
| Applicant: | Cadila Pharms Ltd |
| Ingredient: | glyburide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE | glyburide | TABLET;ORAL | 203379 | ANDA | A-S Medication Solutions | 50090-6196 | 50090-6196-0 | 30 TABLET in 1 BOTTLE (50090-6196-0) |
| GLYBURIDE | glyburide | TABLET;ORAL | 203379 | ANDA | A-S Medication Solutions | 50090-6196 | 50090-6196-1 | 100 TABLET in 1 BOTTLE (50090-6196-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
| Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No | ||||
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