Is there a generic for Dyclonine hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Dyclonine hydrochloride, referencing the brand DYCLONE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dyclonine hydrochloride?

DYCLONE (NDA 009925, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dyclonine hydrochloride are approved?

Dyclonine hydrochloride is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Dyclonine hydrochloride

Dyclonine hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DYCLONE · NDA 009925

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
DYCLONERLD×2	ASTRAZENECA	NDA 009925	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
DYCLOPRO×2	SEPTODONT	ANDA 200480	—	Nov 20, 2018

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.

Dyclonine hydrochloride — frequently asked questions

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

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