Skip to contentApplication 074591
- Type
- ANDA
- Sponsor
- DAVA PHARMS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67253-460 | GlyBURIDE | GlyBURIDE | Par Pharmaceutical | ANDA | Current |
| 67253-461 | GlyBURIDE | GlyBURIDE | Par Pharmaceutical | ANDA | Current |
| 67253-462 | GlyBURIDE | GlyBURIDE | Par Pharmaceutical | ANDA | Current |