NDA 012209

SPECTRUM PHARMS

FDA Drug Application

Application #012209

Documents

• Letter: 2016-08-02
• Label: 2016-08-02
• Review: 1999-01-20

Application Sponsors

NDA 012209

SPECTRUM PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	FLUOROURACIL	FLUOROURACIL
002	INJECTABLE;INJECTION	2.5GM/50ML (50MG/ML)	1	FLUOROURACIL	FLUOROURACIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1962-04-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1975-07-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1976-09-29	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1977-05-03
LABELING; Labeling	SUPPL	14	AP	1978-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1983-01-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-11-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1980-04-04	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1982-03-24
LABELING; Labeling	SUPPL	19	AP	1983-05-12
LABELING; Labeling	SUPPL	20	AP	1986-11-26
LABELING; Labeling	SUPPL	21	AP	1984-07-19
LABELING; Labeling	SUPPL	23	AP	1986-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1985-06-26	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1986-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1986-10-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1988-05-19	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1988-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1989-03-20	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1991-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1991-10-18	PRIORITY
LABELING; Labeling	SUPPL	33	AP	1994-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1995-05-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1997-09-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1999-01-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2000-07-31	PRIORITY
EFFICACY; Efficacy	SUPPL	40	AP	2016-07-29	UNKNOWN

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	9	Null	14
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	14
SUPPL	15	Null	14
SUPPL	16	Null	14
SUPPL	17	Null	14
SUPPL	25	Null	14
SUPPL	27	Null	14
SUPPL	28	Null	14
SUPPL	30	Null	14
SUPPL	32	Null	14
SUPPL	35	Null	14
SUPPL	36	Null	14
SUPPL	38	Null	14
SUPPL	39	Null	14
SUPPL	40	Null	7

CDER Filings

SPECTRUM PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12209
            [companyName] => SPECTRUM PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"500MG\/10ML (50MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"2.5GM\/50ML (50MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2016","submission":"SUPPL-40","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/012209s040lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLUOROURACIL","submission":"FLUOROURACIL","actionType":"500MG\/10ML (50MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FLUOROURACIL","submission":"FLUOROURACIL","actionType":"2.5GM\/50ML (50MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-07-29
        )

)