Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020789
Company: CONCORDIA
Company: CONCORDIA
| 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| ZONEGRAN | ZONISAMIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
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 |
|---|---|---|---|---|---|
| 04/13/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020789Orig1s036ltr.pdf | |
| 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 | REMS-Proposal, Labeling |
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 |
|---|---|---|---|---|---|
| 04/13/2020 | 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 | 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 | 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 |
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 | CONCORDIA |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077642 | APOTEX INC |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077645 | AUROBINDO PHARMA LTD |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077813 | BIONPHARMA |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077651 | GLENMARK PHARMS INC |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077636 | GRANULES |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077869 | INVAGEN PHARMS |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077634 | SUN PHARM INDS (IN) |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214492 | UNICHEM |
| ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077625 | ZYDUS LIFESCIENCES |
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 | CONCORDIA |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077642 | APOTEX INC |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077645 | AUROBINDO PHARMA LTD |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077813 | BIONPHARMA |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077651 | GLENMARK PHARMS INC |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077636 | GRANULES |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077869 | INVAGEN PHARMS |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077634 | SUN PHARM INDS (IN) |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 214492 | UNICHEM |
| ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 077625 | ZYDUS LIFESCIENCES |