Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021348
Company: ACTELION PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZAVESCA MIGLUSTAT 100MG CAPSULE;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
07/31/2003 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21348ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-348_Zavesca.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2019 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021348Orig1s015ltr.pdf
01/15/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/10/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021348Orig1s010ltr.pdf
11/23/2010 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021348s008ltr.pdf
02/29/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021348s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/10/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf
11/23/2010 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf
02/29/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf
07/31/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf

ZAVESCA

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIGLUSTAT MIGLUSTAT 100MG CAPSULE;ORAL Prescription No AB 208342 AMERIGEN PHARMS LTD
ZAVESCA MIGLUSTAT 100MG CAPSULE;ORAL Prescription Yes AB 021348 ACTELION PHARMS LTD

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