Application 204721
- Type
- ANDA
- Sponsor
- UNIQUE PHARM LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | TABLET;ORAL | 1MG | No | No |
| 002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-126 | Tolterodine Tartrate | Tolterodine Tartrate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-126 | Tolterodine Tartrate | Tolterodine Tartrate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-127 | Tolterodine Tartrate | Tolterodine Tartrate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-127 | Tolterodine Tartrate | Tolterodine Tartrate | Rising Pharma Holdings, Inc. | ANDA | Current |