Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071535
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-Container/Carton Labels, Labeling-Package Insert

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 PHARMA INC
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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