Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083778
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMOSONE HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 0.5%;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
08/13/1976 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
08/20/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/08/1991 SUPPL-7 Labeling

Label is not available on this site.

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