Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1.87GM/100ML | 0 | SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER | SODIUM LACTATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1992-04-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1998-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-12-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-04-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-07-01 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 20004
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM LACTATE 1\/6 MOLAR IN PLASTIC CONTAINER","activeIngredients":"SODIUM LACTATE","strength":"1.87GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SODIUM LACTATE 1\/6 MOLAR IN PLASTIC CONTAINER","submission":"SODIUM LACTATE","actionType":"1.87GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)