Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020789
Company: ADVANZ PHARMA

• Medication Guide

• Other Important Information from FDA

Products on NDA 20789

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZONEGRAN	ZONISAMIDE	100MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
ZONEGRAN	ZONISAMIDE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
ZONEGRAN	ZONISAMIDE	25MG	CAPSULE;ORAL	Prescription	AB	Yes	No

Labels for NDA 020789

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2020	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf
04/06/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf
06/19/2015	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf
01/26/2012	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf
09/23/2011	SUPPL-30	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf
09/23/2011	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf
04/19/2010	SUPPL-26	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/19/2010	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/19/2010	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/23/2009	SUPPL-25	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
04/23/2009	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
04/23/2009	SUPPL-22	REMS	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
11/20/2006	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf
08/22/2003	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf
10/07/2002	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf
03/27/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf