NDA 019649

SUN PHARM INDS INC

FDA Drug Application

Application #019649

Documents

• Letter: 2001-04-11
• Letter: 2008-11-25
• Label: 2004-06-04
• Label: 2010-04-07
• Letter: 2007-03-23
• Letter: 2008-01-09
• Letter: 2010-04-08
• Label: 2007-03-15
• Label: 2009-01-21

Application Sponsors

NDA 019649

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

1

FLUMADINE

RIMANTADINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-10-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-11-08	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2001-04-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-03-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2008-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2008-12-18	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2008-11-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2010-04-05	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-10-19	PRIORITY

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	7
SUPPL	18	Null	0

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19649
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUMADINE","activeIngredients":"RIMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/05\/2010","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019649s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019649s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2007","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019649s010,019650s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2001","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19650S4lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLUMADINE","submission":"RIMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-04-05
        )

)