Application 201509
- Type
- ANDA
- Sponsor
- PAR FORM
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 5MG | No | No |
| 002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-903 | Zolpidem tartrate | Zolpidem tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-903 | Zolpidem tartrate | Zolpidem tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-904 | Zolpidem tartrate | Zolpidem tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-904 | Zolpidem tartrate | Zolpidem tartrate | Par Pharmaceutical, Inc. | ANDA | Current |