Is there a generic for Chloroquine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Chloroquine hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Chloroquine hydrochloride?

ARALEN HYDROCHLORIDE (NDA 006002, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chloroquine hydrochloride are approved?

Chloroquine hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Chloroquine hydrochloride

Chloroquine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ARALEN HYDROCHLORIDE · NDA 006002

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ARALEN HYDROCHLORIDE	SANOFI AVENTIS US	NDA 006002	—	Approved Prior to Jan 1, 1982

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.

Chloroquine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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