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Application 077884
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 12634-943 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | APOTHECA, INC | ANDA | Current |
| 12634-944 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | APOTHECA, INC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31297 | ORIG | 2007-05-01 |