Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087102
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Discontinued None 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-29 Labeling

Label is not available on this site.

03/29/1993 SUPPL-28 Labeling

Label is not available on this site.

03/29/1993 SUPPL-27 Labeling

Label is not available on this site.

11/16/1992 SUPPL-26 Labeling

Label is not available on this site.

03/15/1991 SUPPL-24 Labeling

Label is not available on this site.

01/07/1991 SUPPL-23 Labeling

Label is not available on this site.

09/19/1989 SUPPL-21 Labeling

Label is not available on this site.

01/03/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/13/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/25/1988 SUPPL-18 Labeling

Label is not available on this site.

10/07/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/10/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

03/29/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/15/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/03/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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