Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089440
Company: GENUS
Company: GENUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;1% | AEROSOL, METERED;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1988 | 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 |
|---|---|---|---|---|---|
| 08/11/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/07/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/07/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |