Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | 2.5GM/100ML | 0 | DEXTROSE 2.5% IN PLASTIC CONTAINER | DEXTROSE |
| 002 | INJECTABLE;INJECTION | 5GM/100ML | 1 | DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE |
| 003 | INJECTABLE;INJECTION | 7.7GM/100ML | 0 | DEXTROSE 7.7% IN PLASTIC CONTAINER | DEXTROSE |
| 004 | INJECTABLE;INJECTION | 10GM/100ML | 1 | DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE |
| 005 | INJECTABLE;INJECTION | 70GM/100ML | 1 | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1988-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-12-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-11-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1989-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1990-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1990-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-03-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-03-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2004-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2014-08-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2015-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-11-20 | STANDARD |
Submissions Property Types
| 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 | 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 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
TE Codes
| 002 | Prescription | AP |
| 004 | Prescription | AP |
| 005 | Prescription | AP |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 19626
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROSE 10% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DEXTROSE 2.5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"2.5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DEXTROSE 7.7% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"7.7GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 70% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"70GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/18\/2015","submission":"SUPPL-30","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019626s030lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"02\/13\/2004","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19626scs019_dextrose_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"DEXTROSE 10% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"10GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEXTROSE 2.5% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"2.5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEXTROSE 7.7% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"7.7GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 70% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"70GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-02-18
)
)