Documents
Application Sponsors
| NDA 017015 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 2MG/ML | 1 | PAVULON | PANCURONIUM BROMIDE |
| 002 | INJECTABLE;INJECTION | 1MG/ML | 1 | PAVULON | PANCURONIUM BROMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1972-10-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 1974-11-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1974-10-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1975-09-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1977-01-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-03-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1982-03-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 1986-04-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-06-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1987-10-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1993-03-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 1991-07-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-10-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-05-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-02-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-03-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 2010-11-24 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 3 | 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 | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17015
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"PAVULON","activeIngredients":"PANCURONIUM BROMIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PAVULON","activeIngredients":"PANCURONIUM BROMIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/24\/2010","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/017015s023lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PAVULON","submission":"PANCURONIUM BROMIDE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PAVULON","submission":"PANCURONIUM BROMIDE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2010-11-24
)
)