Lofexidine hydrochloride
Lofexidine hydrochloride: 1 brand, 3 generics; first approved May 16, 2018; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- BIOCORRX PHARMSNDA 2092292018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.18MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (3)
- LOFEXIDINE HYDROCHLORIDENOVITIUM PHARMAANDA 2199172025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.18MG BASE TABLET ORAL Rx AB - LOFEXIDINE HYDROCHLORIDEMSNANDA 2186992025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.18MG BASE TABLET ORAL Rx AB - LOFEXIDINE HYDROCHLORIDEREGCON HOLDINGSANDA 2186132024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.18MG BASE TABLET ORAL Rx AB
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2018–2025 across 4 FDA applications.
Lofexidine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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