Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 083778
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAMOSONE | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 0.5%;1% | CREAM;TOPICAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 08/13/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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