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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215106
Company: AMNEAL

Products on ANDA 215106

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215106

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215106Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215106

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	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

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

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