Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 40MG/100ML | 1 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 80MG/100ML | 1 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% | DOPAMINE HYDROCHLORIDE |
| 003 | INJECTABLE;INJECTION | 160MG/100ML | 1 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE |
| 004 | INJECTABLE;INJECTION | 320MG/100ML | 1 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% | DOPAMINE HYDROCHLORIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1988-01-20 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1990-10-04 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1996-02-07 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1997-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-01-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2013-03-19 | STANDARD |
Submissions Property Types
TE Codes
| 002 | Prescription | AP |
| 003 | Prescription | AP |
| 004 | Prescription | AP |
CDER Filings
B BRAUN
cder:Array
(
[0] => Array
(
[ApplNo] => 19099
[companyName] => B BRAUN
[docInserts] => ["",""]
[products] => [{"drugName":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"80MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"320MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"40MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"160MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%","submission":"DOPAMINE HYDROCHLORIDE","actionType":"80MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%","submission":"DOPAMINE HYDROCHLORIDE","actionType":"320MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DOPAMINE HYDROCHLORIDE","actionType":"40MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DOPAMINE HYDROCHLORIDE","actionType":"160MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)