Application Sponsors
ANDA 208580 | MYLAN LABS LTD | |
Marketing Status
Application Products
001 | INJECTABLE;IV (INFUSION) | EQ 40MG BASE/VIAL | 0 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-04-08 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2021-04-08 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 15 |
CDER Filings
MYLAN LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208580
[companyName] => MYLAN LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-05-04
)
)