Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012674
Company: ASPEN GLOBAL INC
Company: ASPEN GLOBAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEXADROL | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/1960 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/1987 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1984 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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