NDA 010841

RECORDATI RARE

FDA Drug Application

Application #010841

Documents

• Letter: 2003-10-01
• Letter: 2007-02-12
• Letter: 2009-04-29
• Letter: 2011-06-02
• Letter: 2003-10-01
• Letter: 2010-06-14
• Label: 2007-02-21
• Label: 2009-04-28
• Label: 2010-06-14
• Medication Guide: 2010-06-24

Application Sponsors

NDA 010841

RECORDATI RARE

Marketing Status

• Prescription: 001
• Discontinued: 003

Application Products

001	TABLET;ORAL	250MG	1	PEGANONE	ETHOTOIN
003	TABLET;ORAL	500MG	0	PEGANONE	ETHOTOIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-04-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-02-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-07-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-11-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-11-13	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2003-09-26
LABELING; Labeling	SUPPL	14	AP	2003-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-05-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-04-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-12-10	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2007-02-02	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	22	AP	2010-06-07	STANDARD
REMS; REMS	SUPPL	23	AP	2011-05-31	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2013-01-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2017-02-27	N/A

Submissions Property Types

SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	22	Null	7
SUPPL	23	Null	6
SUPPL	24	Null	0
SUPPL	25	Null	15

CDER Filings

RECORDATI RARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10841
            [companyName] => RECORDATI RARE
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2010\/010841s022MedGuide.pdf"]
            [products] => [{"drugName":"PEGANONE","activeIngredients":"ETHOTOIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PEGANONE","activeIngredients":"ETHOTOIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/07\/2010","submission":"SUPPL-22","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/010841s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2010","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/010841s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/010841s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/010841s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PEGANONE","submission":"ETHOTOIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PEGANONE","submission":"ETHOTOIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-06-07
        )

)