NDA 017422

EMCURE PHARMS LTD

FDA Drug Application

Application #017422

Documents

• Letter: 2003-03-10
• Letter: 2005-10-25
• Letter: 2011-03-16
• Letter: 2016-05-02
• Letter: 2007-08-22
• Letter: 2011-08-15
• Label: 2007-08-21
• Label: 2011-03-14
• Label: 2011-08-12
• Label: 2013-10-22
• Label: 2016-06-17
• Review: 2015-01-28
• Review: 2015-08-21
• Review: 2015-08-21
• Label: 2017-03-27
• Letter: 2017-03-29
• Letter: 2022-02-23

Application Sponsors

NDA 017422

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/VIAL

1

BICNU

CARMUSTINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1977-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-10-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	1979-10-09
LABELING; Labeling	SUPPL	5	AP	1980-11-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-04-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	1982-02-16
LABELING; Labeling	SUPPL	8	AP	1987-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1983-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-02-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	1983-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-12-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	1986-07-11
LABELING; Labeling	SUPPL	16	AP	1986-05-19
LABELING; Labeling	SUPPL	17	AP	1986-05-19
LABELING; Labeling	SUPPL	18	AP	1986-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-08-07	STANDARD
LABELING; Labeling	SUPPL	22	AP	1987-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1989-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1989-09-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1991-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1991-06-13	STANDARD
LABELING; Labeling	SUPPL	31	AP	1992-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1992-07-13	STANDARD
LABELING; Labeling	SUPPL	34	AP	1997-09-10	STANDARD
LABELING; Labeling	SUPPL	35	AP	2003-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2005-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2007-08-17	N/A
LABELING; Labeling	SUPPL	38	AP	2011-03-14	STANDARD
LABELING; Labeling	SUPPL	42	AP	2011-08-11	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2013-09-18	STANDARD
LABELING; Labeling	SUPPL	46	AP	2013-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2014-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	50	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	55	AP	2017-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2021-04-30	N/A

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	7
SUPPL	42	Null	15
SUPPL	45	Null	0
SUPPL	46	Null	15
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	6
SUPPL	55	Null	15

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17422
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BICNU","activeIngredients":"CARMUSTINE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2017","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017422s055lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2016","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017422Orig2s050Lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017422s046lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2011","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017422s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2011","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017422s038lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2007","submission":"SUPPL-37","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017422s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2007","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017422s037lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BICNU","submission":"CARMUSTINE","actionType":"100MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-24
        )

)