Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087104
Company: TARO
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
04/27/1982 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
07/31/1996 SUPPL-30 Labeling

Label is not available on this site.

03/29/1993 SUPPL-28 Labeling

Label is not available on this site.

11/16/1992 SUPPL-27 Labeling

Label is not available on this site.

02/11/1991 SUPPL-25 Labeling

Label is not available on this site.

02/11/1991 SUPPL-24 Labeling

Label is not available on this site.

01/19/1990 SUPPL-23 Labeling

Label is not available on this site.

01/03/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/16/1989 SUPPL-20 Labeling

Label is not available on this site.

10/07/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/13/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/30/1982 SUPPL-3 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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