Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085597
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 20MG/ML INJECTABLE;INJECTION 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
03/14/1979 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
02/19/1999 SUPPL-37 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-35 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/18/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-31 Labeling

Label is not available on this site.

06/13/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/13/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-28 Labeling

Label is not available on this site.

12/01/1992 SUPPL-27 Labeling

Label is not available on this site.

03/18/1991 SUPPL-26 Labeling

Label is not available on this site.

11/21/1989 SUPPL-25 Labeling

Label is not available on this site.

11/29/1988 SUPPL-24 Bioequivalence

Label is not available on this site.

12/28/1988 SUPPL-23 Labeling

Label is not available on this site.

12/28/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/16/1989 SUPPL-21 Labeling

Label is not available on this site.

06/16/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/25/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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