NDA 019998

RECORDATI RARE

FDA Drug Application

Application #019998

Documents

• Letter: 2007-07-16
• Letter: 2010-10-19
• Label: 2007-07-16
• Label: 2018-10-02
• Letter: 2018-10-11

Application Sponsors

NDA 019998

RECORDATI RARE

Marketing Status

• Prescription: 002

Application Products

002

CAPSULE;ORAL

100MG

1

CHEMET

SUCCIMER

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-01-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-05-11	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1992-05-06
LABELING; Labeling	SUPPL	4	AP	1992-02-25
LABELING; Labeling	SUPPL	6	AP	1992-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-04-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-11-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-03-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-12-07	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1999-10-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	2007-07-11	STANDARD
LABELING; Labeling	SUPPL	17	AP	2010-10-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-04-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2016-07-25	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2018-10-02	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	2	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	17	Null	7
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	21	Null	15

CDER Filings

RECORDATI RARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19998
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHEMET","activeIngredients":"SUCCIMER","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/02\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019998s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2007","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019998s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CHEMET","submission":"SUCCIMER","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-02
        )

)