Application Sponsors
ANDA 215638 | XIAMEN LP PHARM CO | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | 0 | TOPIRAMATE | TOPIRAMATE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | 0 | TOPIRAMATE | TOPIRAMATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-07-29 | STANDARD |
Submissions Property Types
CDER Filings
XIAMEN LP PHARM CO
cder:Array
(
[0] => Array
(
[ApplNo] => 215638
[companyName] => XIAMEN LP PHARM CO
[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":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/29\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-07-29
)
)