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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021348
Company: ACTELION

Products on NDA 021348

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZAVESCA	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021348

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
12/08/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021348s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021348Orig1s016ltr.pdf
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

Labels for NDA 021348

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021348s016lbl.pdf
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

Therapeutic Equivalents for NDA 021348

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	ANI PHARMS
MIGLUSTAT	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	No	AB	209325	BRECKENRIDGE
YARGESA	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	No	AB	209821	EDENBRIDGE PHARMS
ZAVESCA	MIGLUSTAT	100MG	CAPSULE;ORAL	Prescription	Yes	AB	021348	ACTELION

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