Application Sponsors
ANDA 091392 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 5MG BASE/ML | 0 | METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2013-04-19 | |
LABELING; Labeling | SUPPL | 3 | AP | 2019-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-10-27 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 6 | Null | 15 |
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 91392
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)