Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088316
Company: HIKMA

Products on ANDA 088316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1983	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
09/30/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
12/01/2008	SUPPL-23	Labeling		Label is not available on this site.
07/27/2005	SUPPL-22	Labeling		Label is not available on this site.
10/30/2001	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/22/1995	SUPPL-15	Labeling		Label is not available on this site.
05/31/1995	SUPPL-14	Manufacturing (CMC)		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.
01/06/1992	SUPPL-11	Labeling		Label is not available on this site.
11/30/1990	SUPPL-10	Labeling		Label is not available on this site.
01/24/1990	SUPPL-9	Labeling		Label is not available on this site.
05/30/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/03/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/03/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/21/1985	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/17/1984	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.

Therapeutic Equivalents for ANDA 088316

DEXAMETHASONE

TABLET;ORAL; 6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	088481	ALVOGEN
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	215106	AMNEAL
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	217695	APOTEX
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	217001	BIONPHARMA
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	Yes	AB	088316	HIKMA
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	215604	NOVITIUM PHARMA
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	No	AB	216282	ZYDUS LIFESCIENCES