ALLERGAN FDA Approval NDA 206494

NDA 206494

ALLERGAN

FDA Drug Application

Application #206494

Documents

Summary Review2015-03-12
Letter2015-02-27
Letter2015-09-04
Letter2016-06-23
Label2015-02-27
Label2015-09-04
Label2016-06-23
Review2015-03-12
Label2017-01-26
Letter2017-01-30
Label2018-02-02
Letter2018-02-02
Label2019-03-15
Label2019-03-15
Letter2019-03-15
Letter2019-03-15
Pediatric Other1900-01-01
Letter2020-12-09
Label2020-12-10
Label2022-12-21
Letter2022-12-22

Application Sponsors

NDA 206494ALLERGAN

Marketing Status

Prescription001

Application Products

001POWDER;IV (INFUSION)EQ 0.5GM BASE;2GM/VIAL1AVYCAZAVIBACTAM SODIUM; CEFTAZIDIME

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2015-02-25PRIORITY
EFFICACY; EfficacySUPPL2AP2016-06-22PRIORITY
EFFICACY; EfficacySUPPL3AP2017-01-26PRIORITY Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
EFFICACY; EfficacySUPPL4AP2018-02-01PRIORITY
EFFICACY; EfficacySUPPL5AP2019-03-14PRIORITY
EFFICACY; EfficacySUPPL6AP2019-03-14PRIORITY
LABELING; LabelingSUPPL7AP2020-12-07STANDARD
EFFICACY; EfficacySUPPL11AP2022-12-20PRIORITY

Submissions Property Types

ORIG1Null2
SUPPL2Null15
SUPPL3Null6
SUPPL4Null6
SUPPL5Null7
SUPPL6Null7
SUPPL7Null15
SUPPL11Null6

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206494
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AVYCAZ","activeIngredients":"AVIBACTAM SODIUM; CEFTAZIDIME","strength":"EQ 0.5GM BASE;2GM\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/14\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206494s005,s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206494s005,s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206494s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206494s003lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/22\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206494s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206494s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206494s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206494s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/25\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206494s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206494Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206494Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206494Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/14\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206494s005,s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/14\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206494s005,s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/01\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206494s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206494Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206494s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206494Orig1s003ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"06\/22\/2016","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206494s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206494Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"09\/02\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206494s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206494orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-03-14
        )

)
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