Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086155
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% 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
07/24/1978 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
04/28/2005 SUPPL-42 Labeling

Label is not available on this site.

06/20/2001 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

04/29/1993 SUPPL-36 Labeling

Label is not available on this site.

11/23/1992 SUPPL-35 Labeling

Label is not available on this site.

11/16/1992 SUPPL-34 Labeling

Label is not available on this site.

01/23/1991 SUPPL-32 Labeling

Label is not available on this site.

01/03/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/15/1989 SUPPL-29 Labeling

Label is not available on this site.

11/13/1989 SUPPL-28 Labeling

Label is not available on this site.

07/31/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-26 Labeling

Label is not available on this site.

01/08/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/10/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/13/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/02/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/18/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/03/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/09/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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