Documents
Application Sponsors
ANDA 091376 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | 0 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE |
FDA Submissions
Submissions Property Types
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 91376
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOPOTECAN HYDROCHLORIDE","submission":"TOPOTECAN HYDROCHLORIDE","actionType":"EQ 4MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)