Application 213226
- Type
- ANDA
- Sponsor
- MSN LABORATORIES PRIVATE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 82.5MG | No | No |
| 002 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 165MG | No | No |
| 003 | PREGABALIN | PREGABALIN | TABLET, EXTENDED RELEASE;ORAL | 330MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55700-955 | PREGABALIN | PREGABALIN | Quality Care Products, LLC | ANDA | Current |
| 55700-956 | PREGABALIN | PREGABALIN | Quality Care Products, LLC | ANDA | Current |
| 69539-127 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-127 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-128 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-128 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-129 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 69539-129 | PREGABALIN | PREGABALIN | MSN LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 72205-077 | PREGABALIN | PREGABALIN | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-078 | PREGABALIN | PREGABALIN | Novadoz Pharmaceuticals LLC | ANDA | Current |
| 72205-079 | PREGABALIN | PREGABALIN | Novadoz Pharmaceuticals LLC | ANDA | Current |