← FDA DRUG APPROVALS

FDA NDA · NDA208610

BAXDELA

delafloxacin meglumine

Sponsor: MELINTA

APPLICATION
NDA208610
TYPE
NDA
ORIGINAL APPROVAL
2017-06-19
LATEST ACTION
2019-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BAXDELA · ReferencePrescription
DELAFLOXACIN MEGLUMINE EQ 450MG BASE · TABLET · ORAL

Approval history

2019-10-24Efficacy · Supplement 7 · priority — Letter ↗AP
2019-05-03Labeling · Supplement 6 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 5 · standard — Label ↗AP
2017-06-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →