NDA 050734

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050734

Documents

• Letter: 2003-05-30
• Letter: 2014-12-05
• Label: 2003-05-06
• Label: 2015-01-09
• Label: 2019-08-05
• Letter: 2019-08-05
• Letter: 2021-02-11
• Label: 2021-02-17
• Label: 2022-04-27
• Letter: 2022-04-29

Application Sponsors

NDA 050734

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

1

IDAMYCIN PFS

IDARUBICIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-02-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	1999-08-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-11-05	STANDARD
LABELING; Labeling	SUPPL	22	AP	2014-12-04	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-08-02	STANDARD
LABELING; Labeling	SUPPL	27	AP	2021-02-10	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-04-27	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	22	Null	31
SUPPL	25	Null	6
SUPPL	27	Null	6
SUPPL	29	Null	15

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

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(
    [0] => Array
        (
            [ApplNo] => 50734
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"IDAMYCIN PFS","activeIngredients":"IDARUBICIN HYDROCHLORIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/10\/2021","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/050734s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050734s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2014","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050734s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/050734s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IDAMYCIN PFS","submission":"IDARUBICIN HYDROCHLORIDE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)