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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020599
Company: COVIS

Products on NDA 020599

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RILUTEK	RILUZOLE	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020599

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020599Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020599s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020599Orig1s019ltr.pdf
04/08/2016	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020599s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020599Orig1s017ltr.pdf
11/16/2009	SUPPL-13	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s013.pdf
07/10/2009	SUPPL-12	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf
07/10/2009	SUPPL-11	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020599s011,s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020599Orig1s011,s012.pdf
09/21/2004	SUPPL-8	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20599s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020599Orig1s008.pdf
04/10/2000	SUPPL-6	Labeling		Label is not available on this site.
05/19/2003	SUPPL-5	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s005.pdf
04/09/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/19/2003	SUPPL-3	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s003.pdf
05/19/2003	SUPPL-2	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20599slr002,003,005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020599Orig1s002.pdf
11/04/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020599

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020599s019lbl.pdf
04/08/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020599s017lbl.pdf
11/16/2009	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf
07/10/2009	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf
07/10/2009	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf

Therapeutic Equivalents for NDA 020599

RILUTEK

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

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