NDA 206334

MELINTA THERAP

FDA Drug Application

Application #206334

Documents

• Letter: 2016-01-21
• Label: 2014-08-08
• Letter: 2014-08-07
• Label: 2016-01-26
• Review: 2014-09-05
• Summary Review: 2014-09-05
• Letter: 2016-10-19
• Label: 2017-02-22
• Label: 2018-03-23
• Letter: 2018-03-28
• Letter: 2019-12-12
• Label: 2019-12-12
• Label: 2021-07-26
• Letter: 2021-07-27
• Letter: 2022-01-18
• Label: 2022-01-20

Application Sponsors

NDA 206334

MELINTA THERAP

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 400MG BASE/VIAL

1

ORBACTIV

ORITAVANCIN DIPHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-08-06	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2016-01-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-10-17	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	4	AP	2018-03-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-12-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-07-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-01-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15

CDER Filings

MELINTA THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206334
            [companyName] => MELINTA THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORBACTIV","activeIngredients":"ORITAVANCIN DIPHOSPHATE","strength":"EQ 400MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206334s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206334s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206334s003lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/20\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206334s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206334s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/06\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206334s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206334Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206334Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206334Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206334s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206334Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206334s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206334Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206334s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206334Orig1s003ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"01\/20\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206334s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206334Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/14\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-11
        )

)