NDA 018878

RECORDATI RARE

FDA Drug Application

Application #018878

Documents

• Letter: 2003-05-30
• Letter: 2007-01-25
• Label: 2007-01-16
• Letter: 2003-05-30
• Letter: 2006-02-08
• Letter: 2010-01-26
• Label: 2006-02-07
• Label: 2010-01-20
• Label: 2021-03-29
• Letter: 2021-03-30

Application Sponsors

NDA 018878

RECORDATI RARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG BASE/VIAL

1

INDOCIN

INDOMETHACIN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1985-01-30	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1985-06-20
LABELING; Labeling	SUPPL	5	AP	1988-06-08
LABELING; Labeling	SUPPL	10	AP	1994-09-21
LABELING; Labeling	SUPPL	11	AP	1994-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-10-14	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1998-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-10-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-11-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-02-12	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2003-05-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-11-08	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2006-02-01	STANDARD
LABELING; Labeling	SUPPL	24	AP	2007-01-12	STANDARD
LABELING; Labeling	SUPPL	27	AP	2010-01-19	UNKNOWN
LABELING; Labeling	SUPPL	29	AP	2021-03-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	27	Null	6
SUPPL	29	Null	15

TE Codes

001

Prescription

AP

CDER Filings

RECORDATI RARE

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(
    [0] => Array
        (
            [ApplNo] => 18878
            [companyName] => RECORDATI RARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOCIN","activeIngredients":"INDOMETHACIN SODIUM","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/19\/2010","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018878s027lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2007","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018878s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2006","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018878s023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INDOCIN","submission":"INDOMETHACIN SODIUM","actionType":"EQ 1MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-01-19
        )

)