Drugs@FDA: FDA-Approved Drugs
Company: MEDIMETRIKS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | AT | Yes | Yes |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | AT | Yes | Yes |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 02/15/1963 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2013 | SUPPL-71 | Manufacturing (CMC) |
Label (PDF)
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf | |
| 09/26/2000 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 11/13/1992 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1995 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 03/06/1995 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 02/13/1990 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1989 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1984 | SUPPL-55 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1983 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 11/19/1982 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1981 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1981 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1980 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/19/1980 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 02/19/1980 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/23/1979 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1979 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1979 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1978 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/04/1977 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 07/08/1976 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 12/12/1975 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/26/1975 | SUPPL-26 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/28/2013 | SUPPL-71 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf |
| 03/28/2013 | SUPPL-71 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf |
SYNALAR
CREAM;TOPICAL; 0.025%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 210747 | COSETTE |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 088169 | FOUGERA PHARMS INC |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 087104 | TARO |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |
CREAM;TOPICAL; 0.01%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | No | AT | 089526 | COSETTE |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | No | AT | 088170 | FOUGERA PHARMS INC |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |
CREAM;TOPICAL; 0.025%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 210747 | COSETTE |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 088169 | FOUGERA PHARMS INC |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 087104 | TARO |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |