Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085084
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 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
06/23/1976 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
03/30/1998 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/30/1998 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/30/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/02/1994 SUPPL-43 Labeling

Label is not available on this site.

12/23/1993 SUPPL-42 Labeling

Label is not available on this site.

02/05/1991 SUPPL-41 Labeling

Label is not available on this site.

06/22/1988 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/29/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/24/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/24/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/15/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/15/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/15/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/11/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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