MERCK SHARP DOHME FDA Approval NDA 021337

NDA 021337

MERCK SHARP DOHME

FDA Drug Application

Application #021337

Documents

Letter2001-11-09
Letter2004-05-26
Letter2005-05-20
Letter2006-08-14
Letter2007-11-19
Letter2008-03-26
Letter2010-01-25
Letter2011-07-25
Letter2009-11-10
Letter2012-03-05
Letter2014-10-02
Label2011-07-25
Label2009-10-14
Label2010-05-28
Label2012-02-22
Label2012-03-07
Label2014-10-02
Review2001-11-09
Letter2004-05-04
Letter2004-09-10
Letter2005-01-26
Letter2005-10-19
Letter2010-05-27
Letter2013-07-26
Label2001-11-09
Label2005-05-20
Label2005-10-19
Label2006-08-11
Label2008-03-27
Label2009-12-15
Label2013-07-30
Review2014-01-16
Label2017-09-13
Letter2017-09-20
Pediatric Medical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-09-14
Label2018-09-19
Label2018-12-20
Letter2018-12-21
Letter2019-09-23
Label2019-10-01
Letter2020-12-23
Label2020-12-28
Letter2022-03-18
Label2022-03-21

Application Sponsors

NDA 021337MERCK SHARP DOHME

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIAL1INVANZERTAPENEM SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2001-11-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-05-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-07-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-12-20STANDARD
LABELING; LabelingSUPPL13AP2004-04-30STANDARD
LABELING; LabelingSUPPL14AP2004-05-20STANDARD
LABELING; LabelingSUPPL15AP2004-09-10STANDARD
LABELING; LabelingSUPPL17AP2005-01-24STANDARD
EFFICACY; EfficacySUPPL18AP2005-05-18PRIORITY
EFFICACY; EfficacySUPPL19AP2005-10-14STANDARD
EFFICACY; EfficacySUPPL21AP2006-08-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2006-12-28N/A
LABELING; LabelingSUPPL26AP2007-11-16STANDARD
LABELING; LabelingSUPPL28AP2008-03-25STANDARD
LABELING; LabelingSUPPL30AP2009-12-13STANDARD
LABELING; LabelingSUPPL31AP2011-07-22STANDARD
LABELING; LabelingSUPPL33AP2009-10-06UNKNOWN
LABELING; LabelingSUPPL34AP2010-05-25UNKNOWN
LABELING; LabelingSUPPL37AP2012-02-17STANDARD
LABELING; LabelingSUPPL38AP2012-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2013-01-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2013-08-05STANDARD
LABELING; LabelingSUPPL41AP2013-07-24STANDARD
LABELING; LabelingSUPPL42AP2014-09-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2015-03-16STANDARD
LABELING; LabelingSUPPL45AP2017-09-08STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL46AP2018-09-12STANDARD
LABELING; LabelingSUPPL47AP2018-12-19STANDARD
LABELING; LabelingSUPPL48AP2019-09-20STANDARD
LABELING; LabelingSUPPL49AP2020-12-22STANDARD
LABELING; LabelingSUPPL51AP2022-03-17STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL13Null9
SUPPL14Null9
SUPPL18Null8
SUPPL30Null7
SUPPL31Null7
SUPPL33Null7
SUPPL34Null6
SUPPL37Null7
SUPPL38Null7
SUPPL39Null0
SUPPL40Null0
SUPPL41Null15
SUPPL42Null6
SUPPL43Null0
SUPPL45Null15
SUPPL46Null15
SUPPL47Null6
SUPPL48Null6
SUPPL49Null7
SUPPL51Null7

TE Codes

001PrescriptionAP

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21337
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"INVANZ","activeIngredients":"ERTAPENEM SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/20\/2019","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021337s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021337s047lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2018","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021337s046lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021337Orig1s045lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/30\/2014","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021337s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2014","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021337s042lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2013","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021337s041lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2012","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021337s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021337s037lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2011","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021337s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2010","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021337s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2009","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021337s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2009","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021337s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021337s028lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2006","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021337s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2005","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021337s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2005","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021337s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21337lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INVANZ","submission":"ERTAPENEM SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-09-20
        )

)
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