Application Sponsors
| ANDA 205656 | GLAND PHARMA LTD | |
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
| UNKNOWN; | ORIG | 1 | AP | 2018-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-02-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205656
[companyName] => GLAND PHARMA LTD
[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":"04\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-05
)
)