NDA 050661

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050661

Documents

• Letter: 2002-09-30
• Letter: 2002-10-11
• Label: 2014-12-10
• Letter: 2014-12-05
• Label: 2019-08-05
• Letter: 2019-08-06
• Letter: 2021-02-11
• Label: 2021-02-17
• Letter: 2022-05-05
• Label: 2022-05-06

Application Sponsors

NDA 050661

PHARMACIA AND UPJOHN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	10MG/VIAL	0	IDAMYCIN	IDARUBICIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	5MG/VIAL	0	IDAMYCIN	IDARUBICIN HYDROCHLORIDE
003	INJECTABLE;INJECTION	20MG/VIAL	0	IDAMYCIN	IDARUBICIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-06-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-04-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-09-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-04-22	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2002-09-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-04-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-11-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-04-02	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2014-12-04	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-02-10	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-04-27	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	14	Null	6
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	7

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50661
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"IDAMYCIN","activeIngredients":"IDARUBICIN HYDROCHLORIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IDAMYCIN","activeIngredients":"IDARUBICIN HYDROCHLORIDE","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IDAMYCIN","activeIngredients":"IDARUBICIN HYDROCHLORIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/10\/2021","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/050661s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050661s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050661s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IDAMYCIN","submission":"IDARUBICIN HYDROCHLORIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IDAMYCIN","submission":"IDARUBICIN HYDROCHLORIDE","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IDAMYCIN","submission":"IDARUBICIN HYDROCHLORIDE","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)