Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089526
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% 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
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
01/25/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/25/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINOLONE ACETONIDE

CREAM;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% CREAM;TOPICAL Prescription No AT 089526 ACP NIMBLE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription No AT 088170 FOUGERA PHARMS INC
SYNALAR FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription Yes AT 012787 MEDIMETRIKS PHARMS

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