NDA 021883

ALLERGAN

FDA Drug Application

Application #021883

Documents

• Letter: 2014-05-27
• Label: 2014-05-27
• Label: 2016-01-26
• Review: 2014-06-25
• Summary Review: 2014-06-25
• Letter: 2015-12-22
• Letter: 2016-01-21
• Letter: 2018-07-26
• Label: 2018-09-07
• Label: 2021-07-23
• Letter: 2021-07-26

Application Sponsors

NDA 021883

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 500MG BASE/VIAL

1

DALVANCE

DALBAVANCIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-05-23	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2015-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2016-01-20	PRIORITY 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	2016-01-20	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2018-07-24	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2021-07-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	0
SUPPL	7	Null	7
SUPPL	10	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21883
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALVANCE","activeIngredients":"DALBAVANCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/24\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021883s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021883s003lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021883s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DALVANCE","submission":"DALBAVANCIN HYDROCHLORIDE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-24
        )

)