Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086595
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 10MG 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
04/10/1979 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
12/01/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-32 Labeling

Label is not available on this site.

04/03/1992 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/19/1991 SUPPL-28 Labeling

Label is not available on this site.

12/12/1994 SUPPL-27 Labeling

Label is not available on this site.

12/12/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/12/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/12/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/01/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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