Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018849
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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