Application Sponsors
ANDA 076020 | INTL MEDICATION | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | 0 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | EQ 5MG BASE/ML | 0 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2004-07-16 | |
LABELING; Labeling | SUPPL | 2 | AP | 2017-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2017-08-17 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 76020
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)