ANDA 062926

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #062926

Application Sponsors

ANDA 062926

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	10MG/VIAL	0	RUBEX	DOXORUBICIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	50MG/VIAL	0	RUBEX	DOXORUBICIN HYDROCHLORIDE
003	INJECTABLE;INJECTION	100MG/VIAL	0	RUBEX	DOXORUBICIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1989-04-13
LABELING; Labeling	SUPPL	2	AP	1997-07-11
LABELING; Labeling	SUPPL	3	AP	1998-12-01
LABELING; Labeling	SUPPL	4	AP	1999-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-05-11
LABELING; Labeling	SUPPL	7	AP	2001-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-11-02

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62926
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUBEX","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RUBEX","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RUBEX","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RUBEX","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RUBEX","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RUBEX","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"100MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)