Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085368
Company: LEGACY PHARMA
Company: LEGACY PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAMOSONE | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE | 1%;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 |
|---|---|---|---|---|---|---|---|
| 01/07/1977 | 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 |
|---|---|---|---|---|---|
| 12/06/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/21/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/21/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/05/2001 | SUPPL-20 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 09/21/2000 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/11/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/03/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/03/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/03/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/07/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/27/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/27/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/21/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |