Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020599
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RILUTEK RILUZOLE 50MG TABLET;ORAL Prescription AB Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 PHARMA BV
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 204048 ALKEM LABS LTD
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 091300 APOTEX CORP
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 203042 MYLAN PHARMS INC
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 091417 SUN PHARM INDS LTD

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