Application Sponsors
NDA 018014 | INTL MEDICATION | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 40MG/ML | 0 | DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1981-05-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-05-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-02-21 | |
LABELING; Labeling | SUPPL | 17 | AP | 1991-06-12 | |
LABELING; Labeling | SUPPL | 18 | AP | 1991-10-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-08-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1992-12-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1993-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-01-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1994-06-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1995-09-19 | |
Submissions Property Types
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18014
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)