Application 202759
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 1MG | No | No |
| 002 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 2MG | No | No |
| 003 | GLIMEPIRIDE | GLIMEPIRIDE | TABLET;ORAL | 4MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-773 | Glimepiride | Glimepiride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-774 | Glimepiride | Glimepiride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-775 | Glimepiride | Glimepiride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 50090-6322 | Glimepiride | Glimepiride | A-S Medication Solutions | ANDA | Current |
| 57237-151 | Glimepiride | Glimepiride | Citron Pharma LLC | ANDA | Current |
| 57237-152 | Glimepiride | Glimepiride | Citron Pharma LLC | ANDA | Current |
| 57237-153 | Glimepiride | Glimepiride | Citron Pharma LLC | ANDA | Current |
| 65862-579 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-579 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-579 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-580 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-580 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-580 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-581 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-581 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-581 | Glimepiride | Glimepiride | Aurobindo Pharma Limited | ANDA | Current |