Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088481
Company: ALVOGEN

Products on ANDA 088481

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET;ORAL	Prescription	AB	No	No
DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET;ORAL	Prescription	BP	No	No
DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET;ORAL	Prescription	BP	No	No
DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088481

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/1983	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
01/14/2022	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
07/24/2008	SUPPL-22	Labeling		Label is not available on this site.
12/06/2002	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/26/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/26/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/12/1997	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/30/1995	SUPPL-16	Labeling		Label is not available on this site.
04/28/1994	SUPPL-15	Labeling		Label is not available on this site.
04/29/1992	SUPPL-14	Labeling		Label is not available on this site.
09/18/1990	SUPPL-13	Labeling		Label is not available on this site.
01/23/1990	SUPPL-12	Labeling		Label is not available on this site.
07/31/1989	SUPPL-11	Labeling		Label is not available on this site.
09/16/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/01/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/01/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/26/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/26/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088481

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

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	088481	ALVOGEN
DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET;ORAL	Prescription	No	AB	215106	AMNEAL
DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET;ORAL	Prescription	No	AB	217695	APOTEX
DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET;ORAL	Prescription	No	AB	217001	BIONPHARMA
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
DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET;ORAL	Prescription	No	AB	216282	ZYDUS LIFESCIENCES