Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085600
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/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-119 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-117 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/06/1998 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

11/18/1998 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

04/10/1997 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-107 Labeling

Label is not available on this site.

09/01/1994 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-105 Labeling

Label is not available on this site.

12/01/1992 SUPPL-104 Labeling

Label is not available on this site.

10/28/1991 SUPPL-103 Labeling

Label is not available on this site.

06/07/1991 SUPPL-102 Labeling

Label is not available on this site.

11/21/1989 SUPPL-101 Labeling

Label is not available on this site.

02/27/1989 SUPPL-99 Labeling

Label is not available on this site.

02/09/1989 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

02/09/1989 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

01/19/1988 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

06/11/1986 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

02/10/1983 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

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