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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089524
Company: COSETTE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT;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
07/26/1988 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
09/10/2017 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.
01/08/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
01/29/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/25/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
05/14/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINOLONE ACETONIDE

OINTMENT;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% OINTMENT;TOPICAL Prescription No AT 089524 COSETTE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 088168 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 040041 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription Yes AT 013960 MEDIMETRIKS PHARMS
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