Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084612
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 4MG 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
07/19/1978 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
12/01/2008 SUPPL-30 Labeling

Label is not available on this site.

07/27/2005 SUPPL-28 Labeling

Label is not available on this site.

08/28/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-20 Labeling

Label is not available on this site.

05/31/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-18 Labeling

Label is not available on this site.

02/08/1994 SUPPL-17 Labeling

Label is not available on this site.

07/02/1991 SUPPL-16 Labeling

Label is not available on this site.

03/15/1991 SUPPL-15 Labeling

Label is not available on this site.

05/30/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/02/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

There are no Therapeutic Equivalents.

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