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): 209229
Company: USWM

Products on NDA 209229

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUCEMYRA	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209229

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209229s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209229Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209229Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2024	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209229Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209229Orig1s007ltr.pdf

Labels for NDA 209229

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209229Orig1s007lbl.pdf
09/05/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209229Orig1s007lbl.pdf
05/16/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209229s000lbl.pdf

Therapeutic Equivalents for NDA 209229

LUCEMYRA

TABLET;ORAL; EQ 0.18MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOFEXIDINE HYDROCHLORIDE	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	No	AB	218613	INDOCO
LUCEMYRA	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	Yes	AB	209229	USWM

Top