NDA 017391

CASPER PHARMA LLC

FDA Drug Application

Application #017391

Documents

• Letter: 2003-07-24
• Letter: 2005-07-29
• Letter: 2008-07-14
• Label: 2005-07-29
• Label: 2008-07-10
• Letter: 2011-05-26
• Letter: 2014-02-11
• Label: 2011-05-25
• Label: 2014-02-07
• Letter: 2018-12-21
• Label: 2018-12-21

Application Sponsors

NDA 017391

CASPER PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

IMURAN

AZATHIOPRINE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1974-07-19	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1982-04-23
LABELING; Labeling	SUPPL	3	AP	1994-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-03-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-09-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-11-09	PRIORITY
LABELING; Labeling	SUPPL	11	AP	2002-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-09-26	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2005-07-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2008-07-09	STANDARD
LABELING; Labeling	SUPPL	15	AP	2011-05-24	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2014-02-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-12-20	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17391
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMURAN","activeIngredients":"AZATHIOPRINE SODIUM","strength":"EQ 100MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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":"12\/20\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/017391s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/016324s037,017391s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017391s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/016324s031,017391s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/016324s030,017391s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IMURAN","submission":"AZATHIOPRINE SODIUM","actionType":"EQ 100MG BASE\/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] => 2018-12-20
        )

)