Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
| Discontinued | 008 |
| Discontinued | 009 |
Application Products
| 001 | SOLUTION;INTRAPERITONEAL | 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML | 0 | DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE |
| 002 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML | 0 | DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| 003 | SOLUTION;INTRAPERITONEAL | 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML | 0 | DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE |
| 004 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML | 0 | DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| 005 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | 0 | DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| 006 | SOLUTION;INTRAPERITONEAL | 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML | 0 | DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE |
| 007 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | 0 | DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| 008 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | 0 | DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
| 009 | SOLUTION;INTRAPERITONEAL | 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML | 0 | DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1981-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-01-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1983-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1983-02-16 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1984-09-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1983-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1983-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1986-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1985-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1986-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1986-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1987-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1986-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1987-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1988-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1988-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1991-11-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1995-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1995-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1998-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2000-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-04-05 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 18460
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"DIALYTE LM\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;1.5GM\/100ML;15MG\/100ML;560MG\/100ML;390MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;1.5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;2.5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"29MG\/100ML;2.5GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;4.25GM\/100ML;15MG\/100ML;560MG\/100ML;390MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE LM\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","strength":"26MG\/100ML;4.25GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE W\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"29MG\/100ML;1.5GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIALYTE W\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","strength":"29MG\/100ML;4.25GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","dosageForm":"SOLUTION;INTRAPERITONEAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIALYTE LM\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;1.5GM\/100ML;15MG\/100ML;560MG\/100ML;390MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;1.5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;2.5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"29MG\/100ML;2.5GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 2.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;5GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;4.25GM\/100ML;15MG\/100ML;560MG\/100ML;390MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE LM\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE","actionType":"26MG\/100ML;4.25GM\/100ML;5MG\/100ML;530MG\/100ML;450MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE W\/ DEXTROSE 1.5% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"29MG\/100ML;1.5GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIALYTE W\/ DEXTROSE 4.25% IN PLASTIC CONTAINER","submission":"CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"29MG\/100ML;4.25GM\/100ML;15MG\/100ML;610MG\/100ML;560MG\/100ML","submissionClassification":"SOLUTION;INTRAPERITONEAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)