Application 211298
- Type
- ANDA
- Sponsor
- UMEDICA LABS PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | TADALAFIL | TADALAFIL | TABLET;ORAL | 5MG | No | No |
| 003 | TADALAFIL | TADALAFIL | TABLET;ORAL | 10MG | No | No |
| 004 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75834-247 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-247 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-247 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-248 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-248 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-248 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-249 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-249 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-249 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-250 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-250 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-250 | Tadalafil | Tadalafil | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |