Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088167
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% 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
12/16/1982 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
04/11/2005 SUPPL-6 Labeling

Label is not available on this site.

06/24/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/09/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

FLUOCINOLONE ACETONIDE

SOLUTION;TOPICAL; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 209913 ENCUBE ETHICALS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 088167 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 209596 GLASSHOUSE PHARMS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 206422 LUPIN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 089124 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription Yes AT 015296 MEDIMETRIKS PHARMS

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