Is there a generic for Cysteamine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cysteamine hydrochloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Cysteamine hydrochloride?

CYSTADROPS (NDA 211302, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cysteamine hydrochloride are approved?

Cysteamine hydrochloride is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Cysteamine hydrochloride

Cysteamine hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CYSTADROPS · NDA 211302

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
CYSTADROPSRLD	RECORDATI RARE	NDA 211302	—	Aug 19, 2020
CYSTARANRLD	LEADIANT BIOSCI INC	NDA 200740	—	Oct 02, 2012

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.

Cysteamine hydrochloride — frequently asked questions

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

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