Application Sponsors
ANDA 087509 | INTL MEDICATION SYS | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 1% | 0 | MEPIVACAINE HYDROCHLORIDE | MEPIVACAINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1982-10-05 | |
LABELING; Labeling | SUPPL | 2 | AP | 1990-08-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-12-13 | |
LABELING; Labeling | SUPPL | 4 | AP | 1992-05-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-02-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-01-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-09-19 | |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 87509
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)