FDA Orange Book · active-ingredient family
Mefloquine hydrochloride
Mefloquine hydrochloride: 2 brands, 4 generics; first approved May 02, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- LARIAMRLDROCHENDA 0195911989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - MEFLOQUINE HYDROCHLORIDEUS ARMY WALTER REEDNDA 0195781989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- MEFLOQUINE HYDROCHLORIDEHIKMA INTL PHARMSANDA 0776992010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - MEFLOQUINE HYDROCHLORIDEHIKMAANDA 0765232004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - MEFLOQUINE HYDROCHLORIDERSBARRANDA 0763922003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - MEFLOQUINE HYDROCHLORIDECHARTWELL RXANDA 0761752002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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
FDA approval span
First approval
38 yr ago
Most recent approval
16 yr 8 mo ago
Approvals span 1989–2010 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Mefloquine 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.
