Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088169
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;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
03/07/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/09/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

FLUOCINOLONE ACETONIDE

CREAM;TOPICAL; 0.025%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210747 ACP NIMBLE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 088169 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 087104 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 012787 MEDIMETRIKS PHARMS

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