Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086156
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROFURAZONE NITROFURAZONE 0.2% OINTMENT;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
08/15/1978 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
09/14/1992 SUPPL-21 Labeling

Label is not available on this site.

07/28/1992 SUPPL-20 Labeling

Label is not available on this site.

08/18/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/11/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/11/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/16/1989 SUPPL-16 Labeling

Label is not available on this site.

08/08/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/25/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/29/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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