Is there a generic for Levobupivacaine hydrochloride?

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

What is the reference-listed drug for Levobupivacaine hydrochloride?

CHIROCAINE (NDA 020997, PURDUE PHARMA LP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Levobupivacaine hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Levobupivacaine hydrochloride

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

Reference-listed drug:CHIROCAINE · NDA 020997

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CHIROCAINERLD×3	PURDUE PHARMA LP	NDA 020997	—	Aug 05, 1999

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.

Levobupivacaine hydrochloride — frequently asked questions

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

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