U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084612
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription AB Yes 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
09/30/2021 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

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

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription No AB 215106 AMNEAL
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription Yes AB 084612 HIKMA
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription No AB 215604 NOVITIUM PHARMA
DEXAMETHASONE DEXAMETHASONE 4MG TABLET;ORAL Prescription No AB 080399 PRASCO
Back to Top