Drugs@FDA: FDA-Approved Drugs
Company: CNTY LINE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDEX | FLUOCINONIDE | 0.05% | SOLUTION;TOPICAL | Prescription | AT | Yes | 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 |
---|---|---|---|---|---|---|---|
04/06/1984 | 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 |
---|---|---|---|---|---|
02/28/2014 | SUPPL-20 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018849Orig1s020ltr.pdf |
12/16/2005 | SUPPL-18 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016908s058,016909s049,017373s038,018849s018ltr.pdf |
09/27/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
11/16/1992 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/24/1992 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/14/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
02/13/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/06/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/19/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/19/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/29/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/13/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/09/1985 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
LIDEX
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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