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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206334
Company: MELINTA THERAP

Summary Review

Products on NDA 206334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORBACTIV	ORITAVANCIN DIPHOSPHATE	EQ 400MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2014	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/2014/206334s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206334Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2022	SUPPL-7	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206334s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206334Orig1s007ltr.pdf
07/23/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206334s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206334Orig1s006ltr.pdf
12/11/2019	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206334s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206334Orig1s005ltr.pdf
03/20/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206334s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206334Orig1s004ltr.pdf
10/17/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (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/2016/206334s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s003ltr.pdf
01/20/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s002ltr.pdf
07/14/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206334

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206334s007lbl.pdf
01/14/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206334s007lbl.pdf
07/23/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206334s006lbl.pdf
12/11/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206334s005lbl.pdf
03/20/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206334s004lbl.pdf
10/17/2016	SUPPL-3	Labeling-Package Insert	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/2016/206334s003lbl.pdf
01/20/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s002lbl.pdf
08/06/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf

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