Application Sponsors
ANDA 207401 | MICRO LABS LTD INDIA | |
Marketing Status
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | 0 | ACETAZOLAMIDE | ACETAZOLAMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-10-01 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MICRO LABS LTD INDIA
cder:Array
(
[0] => Array
(
[ApplNo] => 207401
[companyName] => MICRO LABS LTD INDIA
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"500MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-01
)
)