Application Sponsors
| ANDA 203460 | FRESENIUS KABI USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | 0 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 5MG BASE/ML | 0 | MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | MIDAZOLAM HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-08-22 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-05-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 203460
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/05\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/05\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-26
)
)