Application 084754
- Type
- ANDA
- Sponsor
- ANIMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE | ELIXIR;ORAL | 0.5MG/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53217-310 | Dexamethasone | Dexamethasone | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54879-003 | Dexamethasone | Dexamethasone | STI Pharma LLC | ANDA | Current |
| 54879-003 | Dexamethasone | Dexamethasone | STI Pharma LLC | ANDA | Current |
| 54879-003 | Dexamethasone | Dexamethasone | STI Pharma LLC | ANDA | Current |