Application Sponsors
ANDA 216427 | AMNEALS PHARMS | |
Marketing Status
Application Products
001 | FOR SUSPENSION;ORAL | 40MG/5ML | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-08-04 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AMNEALS PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 216427
[companyName] => AMNEALS PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"40MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)