Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012515
Company: DELCOR ASSET CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENACORT TRIAMCINOLONE DIACETATE EQ 4MG BASE/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
03/21/1961 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/07/1993 SUPPL-21 Labeling

Label is not available on this site.

06/30/1982 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-18 Labeling

Label is not available on this site.

08/21/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-16 Labeling

Label is not available on this site.

07/17/1979 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/02/1978 SUPPL-12 Labeling

Label is not available on this site.

03/13/2009 SUPPL-10 Labeling

Label is not available on this site.

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