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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084275
Company: CHARTWELL MOLECULAR
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
06/27/1974 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
06/07/2024 SUPPL-12 Labeling-Package Insert, Labeling

Label is not available on this site.

06/07/2024 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/25/1988 SUPPL-8 Labeling

Label is not available on this site.

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