Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML | 0 | ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1980-10-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1980-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1980-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1980-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1981-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1984-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1983-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1985-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1986-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1986-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1987-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1988-04-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1990-09-11 | STANDARD |
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 | 18 | Null | 0 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18270
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"ISOLYTE M W\/ DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISOLYTE M W\/ DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)