Application Sponsors
ANDA 211977 | HETERO LABS LTD III | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
002 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-06-02 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 211977
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-06-02
)
)