Is there a generic for Pipecuronium bromide?

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

What is the reference-listed drug for Pipecuronium bromide?

ARDUAN (NDA 019638, ORGANON USA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pipecuronium bromide are approved?

Pipecuronium bromide is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pipecuronium bromide

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

Reference-listed drug:ARDUAN · NDA 019638

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ARDUAN	ORGANON USA INC	NDA 019638	—	Jun 26, 1990

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.

Pipecuronium bromide — frequently asked questions

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

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