Application Sponsors
ANDA 070119 | INTL MEDICATION | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 50MG/ML | 0 | BRETYLIUM TOSYLATE | BRETYLIUM TOSYLATE |
FDA Submissions
| ORIG | 1 | AP | 1986-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-04-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-04-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-07-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-07-31 | |
LABELING; Labeling | SUPPL | 9 | AP | 1992-02-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-10-29 | |
LABELING; Labeling | SUPPL | 13 | AP | 1993-09-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-01-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1994-06-17 | |
LABELING; Labeling | SUPPL | 16 | AP | 1994-11-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-09-19 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 70119
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)