Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084611
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG 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
07/25/1975 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-43 Labeling

Label is not available on this site.

07/14/2005 SUPPL-42 Labeling

Label is not available on this site.

08/28/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-34 Labeling

Label is not available on this site.

05/31/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-32 Labeling

Label is not available on this site.

02/08/1994 SUPPL-31 Labeling

Label is not available on this site.

07/30/1991 SUPPL-30 Labeling

Label is not available on this site.

12/06/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/06/1991 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/01/1991 SUPPL-26 Labeling

Label is not available on this site.

01/12/1990 SUPPL-25 Labeling

Label is not available on this site.

05/30/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/15/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/02/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

DEXAMETHASONE

There are no Therapeutic Equivalents.

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