Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089472
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
U-CORT HYDROCORTISONE ACETATE 1% CREAM;TOPICAL Prescription 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
06/13/1988 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
06/17/2013 SUPPL-23 Labeling

Label is not available on this site.

06/07/2006 SUPPL-22 Labeling

Label is not available on this site.

10/04/2006 SUPPL-19 Labeling

Label is not available on this site.

04/24/1997 SUPPL-8 Labeling

Label is not available on this site.

04/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/11/1992 SUPPL-6 Labeling

Label is not available on this site.

10/10/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/05/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/23/1989 SUPPL-1 Labeling

Label is not available on this site.

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