Application 213397
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 2MG | No | No |
| 002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 4MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-191 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-191 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma Limited | ANDA | Current |
| 27241-191 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma Limited | ANDA | Current |
| 27241-192 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-192 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma Limited | ANDA | Current |
| 27241-192 | Tolterodine tartrate | Tolterodine tartrate | Ajanta Pharma Limited | ANDA | Current |