Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011960
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTOCORT TRIAMCINOLONE DIACETATE 2MG/5ML SYRUP;ORAL 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
09/02/1959 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/02/1993 SUPPL-12 Labeling

Label is not available on this site.

02/26/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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