Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085595
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/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
03/26/1979 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-87 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-85 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/18/1998 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-77 Labeling

Label is not available on this site.

09/01/1994 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-75 Labeling

Label is not available on this site.

12/01/1992 SUPPL-74 Labeling

Label is not available on this site.

03/18/1991 SUPPL-73 Labeling

Label is not available on this site.

11/13/1989 SUPPL-72 Labeling

Label is not available on this site.

01/23/1989 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/21/1989 SUPPL-68 Labeling

Label is not available on this site.

12/30/1988 SUPPL-66 Bioequivalence

Label is not available on this site.

06/16/1986 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/16/1984 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

10/16/1984 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

02/10/1983 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

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