Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020789
Company: SUNOVION PHARMS INC
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 CAPSULE;ORAL Discontinued None Yes No
ZONEGRAN ZONISAMIDE 25MG CAPSULE;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/27/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20789ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020789_Zonegran.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020789Orig1s034ltr.pdf
11/12/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/11/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/23/2011 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s030ltr.pdf
05/27/2011 SUPPL-29 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s029ltr.pdf
04/19/2010 SUPPL-26 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf
04/23/2009 SUPPL-25 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf
04/19/2010 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf
04/23/2009 SUPPL-22 REMS Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf
06/19/2015 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020789Orig1s021ltr.pdf
11/20/2006 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020789s019ltr.pdf
01/26/2012 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020789s012ltr.pdf
06/13/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/01/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/07/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20789slr005ltr.pdf
02/06/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/28/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/22/2003 SUPPL-1 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20789scm001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.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-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/23/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.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-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

ZONEGRAN

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZONEGRAN ZONISAMIDE 100MG CAPSULE;ORAL Prescription Yes AB 020789 SUNOVION PHARMS INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077637 MYLAN
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077636 WOCKHARDT
ZONISAMIDE ZONISAMIDE 100MG CAPSULE;ORAL Prescription No AB 077625 ZYDUS PHARMS USA

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZONEGRAN ZONISAMIDE 25MG CAPSULE;ORAL Prescription Yes AB 020789 SUNOVION PHARMS INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077642 APOTEX INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077813 BIONPHARMA INC
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077651 GLENMARK GENERICS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077869 INVAGEN PHARMS
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077637 MYLAN
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077634 SUN PHARM INDS (IN)
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077636 WOCKHARDT
ZONISAMIDE ZONISAMIDE 25MG CAPSULE;ORAL Prescription No AB 077625 ZYDUS PHARMS USA

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