NDA 020038

GENZYME CORP

FDA Drug Application

Application #020038

Documents

• Letter: 2003-08-14
• Letter: 2009-02-13
• Letter: 2010-08-02
• Label: 2007-12-27
• Letter: 2008-01-09
• Label: 2003-04-21
• Label: 2003-08-14
• Label: 2009-02-12
• Label: 2010-07-31
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01

Application Sponsors

NDA 020038

GENZYME CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

FLUDARA

FLUDARABINE PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-12-04	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1992-04-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-01-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-01-07	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1992-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-05-21	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1994-09-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-01-29	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1999-05-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-09-05	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2001-12-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-03-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-07-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-07-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-03-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-05-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-05-01	PRIORITY
EFFICACY; Efficacy	SUPPL	28	AP	2003-08-01	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2007-12-20	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2009-02-10	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2010-07-29	PRIORITY

Submissions Property Types

ORIG	1	Null	14
SUPPL	3	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	8	Null	14
SUPPL	11	Null	14
SUPPL	13	Null	14
SUPPL	14	Null	14
SUPPL	15	Null	14
SUPPL	17	Null	14
SUPPL	18	Null	14
SUPPL	19	Null	14
SUPPL	20	Null	14
SUPPL	21	Null	14
SUPPL	22	Null	14
SUPPL	23	Null	14
SUPPL	24	Null	14
SUPPL	25	Null	14
SUPPL	28	Null	14
SUPPL	31	Null	14
SUPPL	32	Null	14
SUPPL	33	Null	14

CDER Filings

GENZYME CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20038
            [companyName] => GENZYME CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDARA","activeIngredients":"FLUDARABINE PHOSPHATE","strength":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020038s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020038s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2007","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020038s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2003","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20038se8-028_fludara_lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2001","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20038s19lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLUDARA","submission":"FLUDARABINE PHOSPHATE","actionType":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-07-29
        )

)