Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084610
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET;ORAL Prescription AB 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
05/19/1975 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-39 Labeling

Label is not available on this site.

07/14/2005 SUPPL-38 Labeling

Label is not available on this site.

10/30/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-33 Labeling

Label is not available on this site.

05/31/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/14/1995 SUPPL-31 Labeling

Label is not available on this site.

02/08/1994 SUPPL-30 Labeling

Label is not available on this site.

07/30/1991 SUPPL-29 Labeling

Label is not available on this site.

12/06/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

11/15/1990 SUPPL-26 Labeling

Label is not available on this site.

05/30/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 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.

10/28/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/15/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/27/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

DEXAMETHASONE

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET;ORAL Prescription No AB 040700 ECR
DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET;ORAL Prescription No AB 084610 HIKMA
DEXAMETHASONE DEXAMETHASONE 1.5MG TABLET;ORAL Prescription No AB 201270 LARKEN LABS INC

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