Application Sponsors
ANDA 207967 | B BRAUN MEDICAL INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | 0 | MAGNESIUM SULFATE | MAGNESIUM SULFATE |
002 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | 0 | MAGNESIUM SULFATE | MAGNESIUM SULFATE |
003 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | 0 | MAGNESIUM SULFATE | MAGNESIUM SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-04-26 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
B BRAUN MEDICAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207967
[companyName] => B BRAUN MEDICAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"2GM\/50ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/100ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/50ML (80MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-04-26
)
)