Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085979
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 | 2.5%;1% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 06/05/1978 | 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 |
|---|---|---|---|---|---|
| 11/21/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/14/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/14/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/14/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |