Application Sponsors
| ANDA 078400 | HIKMA FARMACEUTICA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 1MG/ML | 0 | BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE |
| 002 | INJECTABLE;INJECTION | 2MG/ML | 0 | BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE |
FDA Submissions
| ORIG | 1 | AP | 2009-05-01 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-09-15 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
HIKMA FARMACEUTICA
cder:Array
(
[0] => Array
(
[ApplNo] => 78400
[companyName] => HIKMA FARMACEUTICA
[docInserts] => ["",""]
[products] => [{"drugName":"BUTORPHANOL TARTRATE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUTORPHANOL TARTRATE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BUTORPHANOL TARTRATE","submission":"BUTORPHANOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUTORPHANOL TARTRATE","submission":"BUTORPHANOL TARTRATE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)