Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 5GM/100ML;900MG/100ML | 0 | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1978-02-08 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1978-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-09-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1979-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1979-10-16 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1979-10-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1980-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1980-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-08-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1980-10-24 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1983-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1981-10-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1986-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-05-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1985-04-03 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1985-06-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | 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 | 19 | Null | 0 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18026
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)