Details for New Drug Application (NDA): 209229
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NDA 209229 describes LUCEMYRA, which is a drug marketed by Uswm and is included in one NDA. It is available from two suppliers. Additional details are available on the LUCEMYRA profile page.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Four suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Four suppliers are 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 |
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 AUTHORIZED GENERIC | Prasco Laboratories | 66993-345 | 66993-345-37 | 1 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE |
| LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-345 | 66993-345-76 | 1 BOTTLE in 1 CARTON (66993-345-76) / 96 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: | AB | RLD: | Yes | ||||
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