Application 211889
- Type
- ANDA
- Sponsor
- SUN PHARM INDS 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 |
|---|
| 63304-047 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-047 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-048 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-048 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-049 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-049 | Pregabalin | Pregabalin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |