Application Sponsors
ANDA 080997 | ORGANON USA INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 20MG/ML | 0 | SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1972-09-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-04-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-03-07 | |
LABELING; Labeling | SUPPL | 10 | AP | 1996-04-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-09 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 80997
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SUCCINYLCHOLINE CHLORIDE","submission":"SUCCINYLCHOLINE CHLORIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)