Documents
Application Sponsors
| NDA 018776 | ORGANON USA INC | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 002 | INJECTABLE;INJECTION | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NORCURON | VECURONIUM BROMIDE |
| 003 | INJECTABLE;INJECTION | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NORCURON | VECURONIUM BROMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1984-04-30 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1984-12-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1987-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1986-05-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1987-12-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1987-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1988-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1992-01-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1989-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-10-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2000-08-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2001-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2010-11-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 18776
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"NORCURON","activeIngredients":"VECURONIUM BROMIDE","strength":"10MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NORCURON","activeIngredients":"VECURONIUM BROMIDE","strength":"20MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NORCURON","submission":"VECURONIUM BROMIDE","actionType":"10MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NORCURON","submission":"VECURONIUM BROMIDE","actionType":"20MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)