Drugs@FDA: FDA-Approved Drugs
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. |
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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. |