Documents
Application Sponsors
ANDA 214810 | AMNEAL PHARMS NY | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-09-08 | STANDARD |
Submissions Property Types
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 214810
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"OBETICHOLIC","activeIngredients":"OBETICHOLIC ACID","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OBETICHOLIC","activeIngredients":"OBETICHOLIC ACID","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214810Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-08
)
)