MERCK SHARP DOHME FDA Approval NDA 050742

NDA 050742

MERCK SHARP DOHME

FDA Drug Application

Application #050742

Documents

Letter2004-02-27
Letter2006-01-30
Letter2008-02-27
Letter2007-10-04
Letter2009-06-17
Letter2009-06-17
Label2004-03-03
Label2004-12-02
Label2006-01-27
Label2007-09-26
Label2008-09-16
Label2009-06-22
Review1997-11-26
Letter2003-01-15
Letter2004-02-27
Letter2006-01-30
Letter2007-10-04
Letter2008-09-16
Letter2009-12-24
Label2003-01-15
Label2004-03-03
Label2006-01-27
Label2007-09-26
Label2009-05-11
Label2009-06-22
Label2009-12-16
Review2005-03-08
Letter2022-03-16
Label2022-03-16

Application Sponsors

NDA 050742MERCK SHARP DOHME

Marketing Status

Discontinued001
Prescription002

Application Products

001TABLET;ORAL6MG0STROMECTOLIVERMECTIN
002TABLET;ORAL3MG1STROMECTOLIVERMECTIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1996-11-22PRIORITY
LABELING; LabelingSUPPL2AP2001-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-08-04
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-11-10
LABELING; LabelingSUPPL5AP2001-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2001-07-17
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-05-28
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-12-12
LABELING; LabelingSUPPL11AP2003-01-15STANDARD
LABELING; LabelingSUPPL12AP2004-02-12STANDARD
LABELING; LabelingSUPPL13AP2004-02-12STANDARD
LABELING; LabelingSUPPL15AP2004-11-18STANDARD
LABELING; LabelingSUPPL17AP2006-01-20STANDARD
LABELING; LabelingSUPPL18AP2006-01-20STANDARD
LABELING; LabelingSUPPL19AP2007-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2008-02-26
LABELING; LabelingSUPPL21AP2007-09-26STANDARD
LABELING; LabelingSUPPL22AP2008-09-12STANDARD
LABELING; LabelingSUPPL23AP2009-05-01STANDARD
LABELING; LabelingSUPPL24AP2009-06-11STANDARD
LABELING; LabelingSUPPL25AP2009-06-11STANDARD
LABELING; LabelingSUPPL26AP2009-12-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2015-04-07
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2015-05-11
LABELING; LabelingSUPPL30AP2022-03-14STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL13Null9
SUPPL20Null0
SUPPL26Null7
SUPPL27Null0
SUPPL28Null0
SUPPL30Null7

TE Codes

002PrescriptionAB

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50742
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"STROMECTOL","activeIngredients":"IVERMECTIN","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STROMECTOL","activeIngredients":"IVERMECTIN","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/15\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050742s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2009","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050742s024s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050742s024s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2009","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050742s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2008","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050742s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050742s019s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050742s019s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050742s017,s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050742s017,s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2004","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50742s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50742slr012,013_stomectol_lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2004","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50742slr012,013_stomectol_lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2003","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50742slr011_stromectol_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"STROMECTOL","submission":"IVERMECTIN","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STROMECTOL","submission":"IVERMECTIN","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-12-15
        )

)
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