NDA 021903

RECORDATI RARE

FDA Drug Application

Application #021903

Documents

• Letter: 2008-09-16
• Letter: 2009-12-31
• Letter: 2013-12-05
• Letter: 2016-01-15
• Label: 2010-01-04
• Label: 2016-01-26
• Review: 2008-04-22
• Label: 2006-04-14
• Label: 2013-12-04
• Label: 2017-10-17
• Letter: 2017-10-18
• Letter: 2019-08-15
• Label: 2021-03-29
• Letter: 2021-03-30

Application Sponsors

NDA 021903

RECORDATI RARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

1

NEOPROFEN

IBUPROFEN LYSINE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2006-04-13	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2008-09-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-02-28	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2013-12-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-01-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-10-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-03-26	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	6
SUPPL	7	Null	14
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	31
SUPPL	11	Null	15
SUPPL	12	Null	6

TE Codes

001

Prescription

AP

CDER Filings

RECORDATI RARE

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(
    [0] => Array
        (
            [ApplNo] => 21903
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOPROFEN","activeIngredients":"IBUPROFEN LYSINE","strength":"EQ 20MG BASE\/2ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/16\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021903s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021903s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021903s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021903s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021903lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NEOPROFEN","submission":"IBUPROFEN LYSINE","actionType":"EQ 20MG BASE\/2ML (EQ 10MG BASE\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-10-16
        )

)