Application 074792
- Type
- ANDA
- Sponsor
- MYLAN
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 | 6MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1113 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1113 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1125 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1125 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1142 | Glyburide | glyburide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-1142 | Glyburide | glyburide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43063-119 | Glyburide | glyburide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-120 | Glyburide | glyburide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8445 | ORIG | 1998-06-26 |