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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021883
Company: ABBVIE

Summary Review

Products on NDA 021883

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DALVANCE	DALBAVANCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021883

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021883Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2021	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021883s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021883Orig1s010ltr.pdf
07/24/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021883Orig1s007ltr.pdf
01/20/2016	SUPPL-4	Labeling		Label is not available on this site.
01/20/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021883Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021883Orig1s003.pdf
12/18/2015	SUPPL-2	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021883Orig1s002ltr.pdf
11/20/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021883

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2021	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021883s010lbl.pdf
07/24/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf
01/20/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf
05/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf

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