Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088248
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML SOLUTION;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/01/1983 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
07/27/2005 SUPPL-20 Labeling

Label is not available on this site.

12/01/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/14/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-14 Labeling

Label is not available on this site.

02/14/1995 SUPPL-13 Labeling

Label is not available on this site.

02/08/1994 SUPPL-12 Labeling

Label is not available on this site.

08/02/1991 SUPPL-11 Labeling

Label is not available on this site.

03/26/1991 SUPPL-10 Labeling

Label is not available on this site.

05/16/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/22/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/01/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/01/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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