Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091417
Company: SUN PHARM INDS LTD

Products on ANDA 091417

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091417

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2013	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
09/09/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/09/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091417

RILUZOLE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RILUTEK	RILUZOLE	50MG	TABLET;ORAL	Prescription	Yes	AB	020599	COVIS
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	204048	ALKEM LABS LTD
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	091394	GLENMARK PHARMS LTD
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076173	IMPAX LABS
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	206045	KENTON
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	203042	MYLAN PHARMS INC
RILUZOLE	RILUZOLE	50MG	TABLET;ORAL	Prescription	No	AB	091417	SUN PHARM INDS LTD