Documents
Application Sponsors
| ANDA 210278 | GLENMARK PHARMS LTD | |
Marketing Status
| None (Tentative Approval) | 001 |
| None (Tentative Approval) | 002 |
| None (Tentative Approval) | 003 |
| None (Tentative Approval) | 004 |
| None (Tentative Approval) | 005 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | 0 | TOPIRAMATE | TOPIRAMATE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | 0 | TOPIRAMATE | TOPIRAMATE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | 0 | TOPIRAMATE | TOPIRAMATE |
| 004 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | 0 | TOPIRAMATE | TOPIRAMATE |
| 005 | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | 0 | TOPIRAMATE | TOPIRAMATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | TA | 2019-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2022-11-21 | STANDARD |
Submissions Property Types
TE Codes
| 001 | Prescription | AB2 |
| 002 | Prescription | AB2 |
| 003 | Prescription | AB2 |
| 004 | Prescription | AB2 |
| 005 | Prescription | AB2 |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210278
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOPIRAMATE","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/22\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210278Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-01-22
)
)