Application Sponsors
ANDA 086402 | INTL MEDICATION | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 0.01MG/ML;1% | 0 | LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1980-02-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-04-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1987-04-27 | |
LABELING; Labeling | SUPPL | 10 | AP | 1988-04-21 | |
LABELING; Labeling | SUPPL | 11 | AP | 1991-06-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-02-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-02-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-08-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-12-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-01-14 | |
LABELING; Labeling | SUPPL | 19 | AP | 1993-10-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-06-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-09-19 | |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 86402
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)