Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087711
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE ACETATE DEXAMETHASONE ACETATE EQ 16MG 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
05/24/1982 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-28 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-26 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-25 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/22/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-22 Labeling

Label is not available on this site.

12/20/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/08/1994 SUPPL-20 Labeling

Label is not available on this site.

05/11/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/25/1992 SUPPL-14 Labeling

Label is not available on this site.

03/21/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/21/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/21/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/19/1988 SUPPL-10 Labeling

Label is not available on this site.

06/16/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/10/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/31/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/08/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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