Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087457
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNACORT HYDROCORTISONE 2.5% 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
06/23/1981 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
02/27/1992 SUPPL-7 Labeling

Label is not available on this site.

06/02/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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