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Generated: April 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209229

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NDA 209229 describes LUCEMYRA, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from one supplier. Additional details are available on the LUCEMYRA profile page.

The generic ingredient in LUCEMYRA is lofexidine hydrochloride. One supplier is listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
Summary for 209229
Applicant:Us Worldmeds Llc
Ingredient:lofexidine hydrochloride
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209229
Generic Entry Date for 209229*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 209229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUCEMYRA lofexidine hydrochloride TABLET;ORAL 209229 NDA US WorldMeds, LLC 27505-050 27505-050-36 1 BOTTLE in 1 CARTON (27505-050-36) > 36 TABLET, FILM COATED in 1 BOTTLE
LUCEMYRA lofexidine hydrochloride TABLET;ORAL 209229 NDA US WorldMeds, LLC 27505-050 27505-050-96 1 BOTTLE in 1 CARTON (27505-050-96) > 96 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.18MG BASE
Approval Date:May 16, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 16, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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