Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;IRRIGATION | 33MG/100ML;30MG/100ML;860MG/100ML | 0 | RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1979-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1979-09-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1980-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1980-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1980-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1981-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-09-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1981-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1985-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1985-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1985-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1987-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1985-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1998-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2004-02-13 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
TE Codes
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18156
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"RINGER'S IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"33MG\/100ML;30MG\/100ML;860MG\/100ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RINGER'S IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"33MG\/100ML;30MG\/100ML;860MG\/100ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)