ANDA 091089

FRESENIUS KABI USA

FDA Drug Application

Application #091089

Documents

• Letter: 2010-12-03

Application Sponsors

ANDA 091089

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 4MG BASE/VIAL

0

TOPOTECAN HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-11-29
LABELING; Labeling	SUPPL	2	AP	2016-02-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-02-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91089
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOPOTECAN HYDROCHLORIDE","submission":"TOPOTECAN HYDROCHLORIDE","actionType":"EQ 4MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)