Is there a generic for Arginine hydrochloride?

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

What is the reference-listed drug for Arginine hydrochloride?

R-GENE 10 (NDA 016931, PHARMACIA AND UPJOHN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Arginine hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Arginine hydrochloride

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

Reference-listed drug:R-GENE 10 · NDA 016931

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
R-GENE 10RLD	PHARMACIA AND UPJOHN	NDA 016931	—	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.

Arginine hydrochloride — frequently asked questions

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

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