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 | 0.01% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 05/27/1964 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 11/19/2012 | SUPPL-64 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/015296Orig1s064ltr.pdf | |
| 11/16/2012 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2000 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1996 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 11/13/1992 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1995 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 02/13/1990 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/1989 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1989 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1985 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1983 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/19/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1981 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1981 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/03/1981 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/19/1980 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/23/1979 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1979 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1979 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/14/1979 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1978 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1977 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1977 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1977 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1976 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/07/1976 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2012 | SUPPL-64 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf |
SYNALAR
SOLUTION;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% | SOLUTION;TOPICAL | Prescription | No | AT | 209596 | CHARTWELL RX |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 209913 | ENCUBE ETHICALS |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 088167 | FOUGERA PHARMS INC |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 206422 | LUPIN |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | No | AT | 089124 | TARO |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.01% | SOLUTION;TOPICAL | Prescription | Yes | AT | 015296 | MEDIMETRIKS PHARMS |