NDA 050682

RECORDATI RARE

FDA Drug Application

Application #050682

Documents

• Letter: 2003-03-26
• Letter: 2004-12-06
• Letter: 2005-08-19
• Letter: 2009-03-17
• Letter: 2012-02-07
• Label: 2009-04-03
• Label: 2012-02-06
• Letter: 2002-10-28
• Letter: 2012-02-07
• Label: 2012-02-06
• Label: 2018-08-16
• Label: 2018-08-17
• Letter: 2018-10-26
• Letter: 2018-10-26

Application Sponsors

NDA 050682

RECORDATI RARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.5MG/VIAL

1

COSMEGEN

DACTINOMYCIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1964-12-10	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1988-03-22
LABELING; Labeling	SUPPL	9	AP	1997-02-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	1997-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-02-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-06-06	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2000-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-03-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-05-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-02-08	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2001-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-02-14	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2002-10-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2003-03-19	STANDARD
LABELING; Labeling	SUPPL	21	AP	2004-11-30	STANDARD
LABELING; Labeling	SUPPL	22	AP	2005-08-17	STANDARD
LABELING; Labeling	SUPPL	25	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	29	AP	2012-02-03	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	2012-02-03	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2015-04-07	PRIORITY
EFFICACY; Efficacy	SUPPL	33	AP	2018-08-15	STANDARD
EFFICACY; Efficacy	SUPPL	34	AP	2018-08-15	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	29	Null	15
SUPPL	30	Null	6
SUPPL	31	Null	0
SUPPL	33	Null	7
SUPPL	34	Null	15

TE Codes

001

Prescription

AP

CDER Filings

RECORDATI RARE

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            [ApplNo] => 50682
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"08\/15\/2018","submission":"SUPPL-34","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050682s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2018","submission":"SUPPL-33","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050682s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050682s029s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050682s029s030lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2009","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050682s025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COSMEGEN","submission":"DACTINOMYCIN","actionType":"0.5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
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        )

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