Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084315
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE ACETATE DEXAMETHASONE ACETATE EQ 8MG BASE/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
11/08/1978 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
12/02/2014 SUPPL-118 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-116 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-115 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/22/1998 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-113 Labeling

Label is not available on this site.

03/21/1994 SUPPL-112 Labeling

Label is not available on this site.

12/20/1993 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

05/11/1992 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

11/08/1989 SUPPL-109 Labeling

Label is not available on this site.

03/19/1991 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

03/19/1991 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

06/16/1986 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

07/25/1983 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

10/15/1982 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

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