Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087916
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 2MG TABLET;ORAL Prescription BP 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
08/26/1982 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
12/01/2008 SUPPL-27 Labeling

Label is not available on this site.

07/14/2005 SUPPL-25 Labeling

Label is not available on this site.

08/28/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-17 Labeling

Label is not available on this site.

05/31/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-15 Labeling

Label is not available on this site.

02/08/1994 SUPPL-14 Labeling

Label is not available on this site.

01/06/1992 SUPPL-13 Labeling

Label is not available on this site.

12/06/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/06/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-10 Labeling

Label is not available on this site.

01/24/1990 SUPPL-9 Labeling

Label is not available on this site.

12/06/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/22/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/17/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

There are no Therapeutic Equivalents.

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