Application 214956
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-148 | GABAPENTIN | gabapentin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-149 | GABAPENTIN | gabapentin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-150 | GABAPENTIN | gabapentin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 43602-469 | GABAPENTIN | gabapentin | Ascent Pharmaceuticals, Inc | ANDA | Current |
| 43602-470 | GABAPENTIN | gabapentin | Ascent Pharmaceuticals, Inc | ANDA | Current |
| 43602-471 | GABAPENTIN | gabapentin | Ascent Pharmaceuticals, Inc | ANDA | Current |