Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 15%(150GM/1000ML) | 0 | AMINO ACIDS | AMINO ACIDS |
002 | INJECTABLE;INJECTION | 15%(300GM/2000ML) | 0 | AMINO ACIDS | AMINO ACIDS |
FDA Submissions
| ORIG | 1 | AP | 2012-04-13 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-01-25 | STANDARD |
Submissions Property Types
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 91112
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"AMINO ACIDS","activeIngredients":"AMINO ACIDS","strength":"15%(150GM\/1000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"AMINO ACIDS","activeIngredients":"AMINO ACIDS","strength":"15%(300GM\/2000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMINO ACIDS","submission":"AMINO ACIDS","actionType":"15%(150GM\/1000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMINO ACIDS","submission":"AMINO ACIDS","actionType":"15%(300GM\/2000ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)