Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019117
Company: TARO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB1 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
06/26/1984 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
11/10/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
10/27/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
06/05/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
07/01/2003 SUPPL-18 Labeling

Label is not available on this site.
05/09/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
09/17/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
05/14/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
09/09/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
02/19/1991 SUPPL-8 Labeling

Label is not available on this site.
11/04/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/30/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/30/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/12/1989 SUPPL-4 Labeling

Label is not available on this site.
03/08/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 210554 AMNEAL
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073085 COSETTE
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073030 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB1 019117 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 071500 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 072488 TEVA

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