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FDA Orange Book · active-ingredient family

Loxapine hydrochloride

Loxapine hydrochloride: 2 brands, 0 generics.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Originator applications

Brand (NDA) products

NDA 017658
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 25MG BASE/MLCONCENTRATEORALDiscontinued
NDA 018039
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 50MG BASE/MLINJECTABLEINJECTIONDiscontinued
Orange Book patent file

Listed patents

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.

Loxapine 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

Agent CTA Background

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