Documents
Application Sponsors
ANDA 212789 | HETERO LABS LTD V | |
Marketing Status
Application Products
001 | FOR SOLUTION;ORAL | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | 0 | SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-07-18 | STANDARD |
Submissions Property Types
CDER Filings
HETERO LABS LTD V
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[labels] =>
[originalApprovals] => [{"actionDate":"07\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-07-18
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)