Application 078129
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 5MG | No | No |
| 002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9962 | Zolpidem | Zolpidem Tartrate | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-9962 | Zolpidem | Zolpidem Tartrate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9963 | Zolpidem | Zolpidem Tartrate | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-9963 | Zolpidem | Zolpidem Tartrate | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23894 | ORIG | 2008-05-14 |