Documents
Application Sponsors
| ANDA 079199 | MYLAN INSTITUTIONAL | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) | 0 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE |
| 002 | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) | 0 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-11-26 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2012-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-04-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 79199
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ROCURONIUM BROMIDE","submission":"ROCURONIUM BROMIDE","actionType":"50MG\/5ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROCURONIUM BROMIDE","submission":"ROCURONIUM BROMIDE","actionType":"100MG\/10ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)