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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216284
Company: ZYDUS LIFESCIENCES

Products on ANDA 216284

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216284

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216284Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 216284

DEXAMETHASONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET;ORAL	Prescription	No	AB	217695	APOTEX
DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET;ORAL	Prescription	Yes	AB	088306	HIKMA
DEXAMETHASONE	DEXAMETHASONE	1MG	TABLET;ORAL	Prescription	No	AB	216284	ZYDUS LIFESCIENCES

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