Application 215604
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1.5MG | No | No |
| 002 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 4MG | No | No |
| 003 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 6MG | No | No |
| 004 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.5MG | No | No |
| 005 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-718 | Dexamethasone | Dexamethasone | American Health Packaging | ANDA | Current |
| 70954-401 | Dexamethasone | Dexamethasone | Novitium Pharma LLC | ANDA | Current |
| 70954-403 | Dexamethasone | Dexamethasone | Novitium Pharma LLC | ANDA | Current |
| 70954-404 | Dexamethasone | Dexamethasone | Novitium Pharma LLC | ANDA | Current |