Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017109
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 20MG TABLET;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
06/28/1974 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
04/14/1980 SUPPL-10 Labeling

Label is not available on this site.

11/01/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1978 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/21/1977 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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