Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 20MG | 0 | FAMOTIDINE | FAMOTIDINE |
002 | TABLET;ORAL | 40MG | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-11-04 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ANNORA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 215767
[companyName] => ANNORA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-11-04
)
)