NDA 050740

ASTELLAS

FDA Drug Application

Application #050740

Documents

• Letter: 2000-01-28
• Letter: 2000-07-18
• Letter: 2012-03-13
• Label: 2000-01-28
• Label: 2000-07-18
• Label: 2003-09-26
• Label: 2012-03-09
• Review: 2009-06-19
• Letter: 2003-09-25
• Letter: 2008-10-14
• Label: 2008-11-07
• Review: 2003-07-31
• Review: 2004-05-27
• Label: 2020-05-13
• Letter: 2020-05-13
• Letter: 2021-02-05
• Letter: 2021-02-05
• Label: 2021-11-10

Application Sponsors

NDA 050740

ASTELLAS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE, LIPOSOMAL;INJECTION

50MG/VIAL

1

AMBISOME

AMPHOTERICIN B

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1997-08-11	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2000-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-03-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-02-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-06-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-07-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-05-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-03-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-03-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-06-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-09-06	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2003-09-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2008-10-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2012-03-08	UNKNOWN Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2014-09-16	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2020-05-12	STANDARD
LABELING; Labeling	SUPPL	33	TA	2020-08-17	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	21	Null	15
SUPPL	23	Null	14
SUPPL	31	Null	6
SUPPL	33	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ASTELLAS

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            [labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050740Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050740Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050740s021lbl.pdf\"}]","notes":"Please see"},{"actionDate":"10\/08\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050740s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2003","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50740slr014_ambisome_lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2000","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/50740S2LBL.PDF\"}]","notes":""},{"actionDate":"01\/28\/2000","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/50-740S001_AmBisome_prntlbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2020-05-12
        )

)