Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080531
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE PREDNISOLONE 5MG 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
05/31/1974 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
10/02/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/2001 SUPPL-10 Labeling

Label is not available on this site.

09/25/2001 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/10/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

06/25/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/23/1988 SUPPL-6 Labeling

Label is not available on this site.

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