Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071535
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
12/02/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/06/2015 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/21/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/18/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/21/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/18/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINONIDE
SOLUTION;TOPICAL; 0.05%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 071535 | COSETTE |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 209699 | ENCUBE ETHICALS |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 072934 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 209118 | GLASSHOUSE PHARMS |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 209283 | MACLEODS PHARMS LTD |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 206003 | NOVEL LABS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 074799 | TARO |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 207554 | TELIGENT |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 208948 | ZYDUS PHARMS |
LIDEX | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | Yes | AT | 018849 | CNTY LINE PHARMS |
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