Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077645
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE;ORAL | Prescription | AB | No | No |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
12/22/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077645ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2023 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/08/2023 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/30/2012 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/29/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2010 | SUPPL-2 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
ZONISAMIDE
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 |
CAPSULE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077642 | APOTEX INC |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077645 | AUROBINDO PHARMA LTD |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077813 | BIONPHARMA |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077651 | GLENMARK PHARMS INC |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077636 | GRANULES |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077869 | INVAGEN PHARMS |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077634 | SUN PHARM INDS (IN) |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214492 | UNICHEM |
ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077625 | ZYDUS LIFESCIENCES |