Documents
Application Sponsors
| NDA 020214 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEMURON | ROCURONIUM BROMIDE |
| 002 | INJECTABLE;INJECTION | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEMURON | ROCURONIUM BROMIDE |
| 003 | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEMURON | ROCURONIUM BROMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1994-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1994-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-06-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-12-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2000-03-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2001-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2004-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2004-08-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2008-08-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-11-22 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2013-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2015-01-06 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2018-07-26 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 30 | Null | 8 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 15 |
| SUPPL | 38 | Null | 15 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20214
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
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[labels] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020214Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020214Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"01\/06\/2015","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020214s036lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2010","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020214s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2008","submission":"SUPPL-30","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020214s030lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZEMURON","submission":"ROCURONIUM BROMIDE","actionType":"50MG\/5ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMURON","submission":"ROCURONIUM BROMIDE","actionType":"10MG\/ML (10MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMURON","submission":"ROCURONIUM BROMIDE","actionType":"100MG\/10ML (10MG\/ML) **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] => 2018-07-26
)
)