Details for New Drug Application (NDA): 074686
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NDA 074686 describes GLYBURIDE (MICRONIZED), which is a drug marketed by Chartwell Rx, Hikma, Natco Pharma, Sanofi Aventis Us, Strides Pharma, and Teva, and is included in six NDAs. It is available from one supplier. Additional details are available on the GLYBURIDE (MICRONIZED) profile page.
The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the glyburide profile page.
The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 074686
| Tradename: | GLYBURIDE (MICRONIZED) |
| Applicant: | Teva |
| Ingredient: | glyburide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8034 | 0093-8034-01 | 100 TABLET in 1 BOTTLE (0093-8034-01) |
| GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8035 | 0093-8035-01 | 100 TABLET in 1 BOTTLE (0093-8035-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Apr 20, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Apr 20, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4.5MG | ||||
| Approval Date: | Apr 20, 1999 | TE: | RLD: | No | |||||
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