Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216035
Company: ALKEM LABS LTD

Products on ANDA 216035

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RILUZOLE	RILUZOLE	50MG/10ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216035

RILUZOLE

SUSPENSION;ORAL; 50MG/10ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RILUZOLE	RILUZOLE	50MG/10ML	SUSPENSION;ORAL	Prescription	No	AB	216035	ALKEM LABS LTD
TIGLUTIK KIT	RILUZOLE	50MG/10ML	SUSPENSION;ORAL	Prescription	Yes	AB	209080	ITALFARMACO SA