Application 074686
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 1.5MG | No | No |
| 002 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 3MG | No | No |
| 003 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 4.5MG | No | No |
| 004 | GLYBURIDE (MICRONIZED) | GLYBURIDE | TABLET;ORAL | 6MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-8034 | Glyburide | Glyburide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8035 | Glyburide | Glyburide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-8036 | Glyburide | Glyburide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42254-281 | Glyburide | Glyburide | Rebel Distributors Corp | ANDA | Current |
| 66336-712 | Glyburide | Glyburide | Dispensing Solutions, Inc. | ANDA | Current |