Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | 0 | LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FDA Submissions
| ORIG | 1 | AP | 1978-02-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1978-09-26 | |
LABELING; Labeling | SUPPL | 3 | AP | 1978-09-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1979-03-29 | |
LABELING; Labeling | SUPPL | 5 | AP | 1979-03-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1979-06-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1979-10-16 | |
LABELING; Labeling | SUPPL | 8 | AP | 1979-10-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1980-02-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-07-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1980-08-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1980-10-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1980-09-25 | |
LABELING; Labeling | SUPPL | 14 | AP | 1983-01-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1981-10-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1986-02-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1985-05-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1985-04-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1985-04-03 | |
LABELING; Labeling | SUPPL | 21 | AP | 1985-08-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-09-11 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18023
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"LACTATED RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LACTATED RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"20MG\/100ML;30MG\/100ML;600MG\/100ML;310MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)