Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016763
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFAMYLON | MAFENIDE ACETATE | EQ 85MG BASE/GM | CREAM;TOPICAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/24/1969 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1999 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/30/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/14/1994 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/02/1994 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/04/1990 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1988 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/01/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 12/11/1984 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 08/24/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 11/03/1983 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/28/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/23/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/11/1977 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/28/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 01/26/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |