Documents
Application Sponsors
ANDA 205933 | ALEMBIC PHARMS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-01-07 | STANDARD |
CDER Filings
ALEMBIC PHARMS LTD
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[ApplNo] => 205933
[companyName] => ALEMBIC PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DRONEDARONE","activeIngredients":"DRONEDARONE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-01-07
)
)