BLA 101063

MERCK

FDA Drug Application

Application #101063

Documents

• Letter: 2004-03-12
• Letter: 2004-07-07
• Letter: 2006-07-25
• Label: 2004-03-12
• Label: 2006-07-21
• Letter: 2007-04-20
• Letter: 2013-07-18
• Label: 2007-04-20
• Label: 2013-07-17

Application Sponsors

BLA 101063

MERCK

Marketing Status

• Prescription: 001

Application Products

001

VIAL

10,000IU/VIAL

0

ELSPAR

ASPARAGINASE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-01-10	UNKNOWN
LABELING; Labeling	SUPPL	5012	AP	2002-08-01	STANDARD
LABELING; Labeling	SUPPL	5036	AP	2004-06-29	STANDARD
LABELING; Labeling	SUPPL	5071	AP	2006-07-21	STANDARD
LABELING; Labeling	SUPPL	5081	AP	2007-03-30	STANDARD
LABELING; Labeling	SUPPL	5121	AP	2010-05-20	STANDARD
LABELING; Labeling	SUPPL	5169	AP	2013-07-16	STANDARD

CDER Filings

MERCK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 101063
            [companyName] => MERCK
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELSPAR","activeIngredients":"ASPARAGINASE","strength":"10,000IU\/VIAL","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/16\/2013","submission":"SUPPL-5169","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/101063s5169lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2007","submission":"SUPPL-5081","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/101063s5081LBL.pdf\"}]","notes":""},{"actionDate":"07\/21\/2006","submission":"SUPPL-5071","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/101063s5071lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2002","submission":"SUPPL-5012","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/aspamer080102LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/10\/1978","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/16\/2013","submission":"SUPPL-5169","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/101063s5169lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/101063Orig1s5169ltr.pdf\"}]","notes":">"},{"actionDate":"05\/20\/2010","submission":"SUPPL-5121","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/30\/2007","submission":"SUPPL-5081","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/101063s5081LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/101063s5081LTR.pdf\"}]","notes":">"},{"actionDate":"07\/21\/2006","submission":"SUPPL-5071","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/101063s5071lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/29\/2004","submission":"SUPPL-5036","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/biologics\\\/2004\\\/101063_5036ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/01\/2002","submission":"SUPPL-5012","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/aspamer080102LB.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/aspamer080102L.pdf\"}]","notes":">"}]
            [actionDate] => 2013-07-16
        )

)