An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208611
Company: MELINTA

Medication Guide

Products on NDA 208611

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BAXDELA	DELAFLOXACIN MEGLUMINE	EQ 300MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208611

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2017	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review	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/2017/208610s000,208611s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208610Orig1s000,208611Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208610Orig1s000,208611Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2023	SUPPL-7	Labeling, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208611s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208611Orig1s007ltr.pdf
10/24/2019	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208610Orig1s007, 208611Orig1s006ltr.pdf
05/03/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208610Orig1s006, 208611Orig1s005ltr.pdf
10/18/2018	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208610Orig1s005,208611Orig1s004ltr.pdf

Labels for NDA 208611

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2023	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208611s007lbl.pdf
12/01/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208611s007lbl.pdf
12/01/2023	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208611s007lbl.pdf
10/24/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf
05/03/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf
05/03/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf
10/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf
10/18/2018	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf
06/19/2017	ORIG-1	Approval	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/2017/208610s000,208611s000lbl.pdf

Top