Details for New Drug Application (NDA): 209229
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
NDA 209229 describes LUCEMYRA, which is a drug marketed by Uswm 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.
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 | ||||||||
Complete Access Available with Subscription
