Application 080354
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISOLONE | PREDNISOLONE | TABLET;ORAL | 5MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23594-505 | MILLIPRED | PREDNISOLONE | Cerecor, Inc. | ANDA | Current |
| 23594-505 | MILLIPRED | PREDNISOLONE | Aytu Therapeutics | ANDA | Current |
| 23594-505 | MILLIPRED | PREDNISOLONE | Aytu Therapeutics | ANDA | Current |
| 23594-505 | MILLIPRED | PREDNISOLONE | Zylera Pharmaceuticals, L | ANDA | Current |
| 73534-505 | MILLIPRED | PREDNISOLONE | Avalo Therapeutics Inc. | ANDA | Current |