Application Sponsors
| ANDA 091065 | SAGENT PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 15MG/ML | 0 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE |
| 002 | INJECTABLE;INJECTION | 30MG/ML | 0 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE |
FDA Submissions
| ORIG | 1 | AP | 2013-11-27 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-04-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91065
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"15MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"30MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)