Drugs@FDA: FDA-Approved Drugs
Company: MEDIMETRIKS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNALAR-HP | FLUOCINOLONE ACETONIDE | 0.2% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 07/25/1967 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/13/1992 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 04/24/1992 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/13/1990 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/10/1989 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/24/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1984 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/07/1983 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1982 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1981 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/10/1981 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1981 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/23/1979 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/13/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/28/1978 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1978 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/30/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1977 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1977 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1977 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |