Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085085
Company: WATSON LABS
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
06/29/1976 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
04/06/1994 SUPPL-25 Labeling

Label is not available on this site.

01/06/1994 SUPPL-24 Labeling

Label is not available on this site.

03/03/1988 SUPPL-23 Labeling

Label is not available on this site.

12/01/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/15/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/23/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/14/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/19/1984 SUPPL-14 Labeling

Label is not available on this site.

10/04/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/29/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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