Application Sponsors
ANDA 083724 | INTL MEDICATION | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 0.2MG/ML | 0 | ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1976-01-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-04-23 | |
LABELING; Labeling | SUPPL | 10 | AP | 1991-12-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-06-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-09-19 | |
LABELING; Labeling | SUPPL | 14 | AP | 1996-09-27 | |
LABELING; Labeling | SUPPL | 15 | AP | 1998-07-16 | |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 83724
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)