Details for New Drug Application (NDA): 209229
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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
Tradename: | LUCEMYRA |
Applicant: | Uswm |
Ingredient: | lofexidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | USWM, LLC | 78670-050 | 78670-050-03 | 1 BOTTLE in 1 CARTON (78670-050-03) / 36 TABLET, FILM COATED in 1 BOTTLE |
LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229 | NDA | USWM, LLC | 78670-050 | 78670-050-36 | 1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.18MG BASE | ||||
Approval Date: | May 16, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 16, 2023 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
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