Is there a generic for Phenmetrazine hydrochloride?

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

What is the reference-listed drug for Phenmetrazine hydrochloride?

PRELUDIN (NDA 011752, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Phenmetrazine hydrochloride are approved?

Phenmetrazine hydrochloride is approved in the following dosage forms: tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Phenmetrazine hydrochloride

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

Reference-listed drug:PRELUDIN · NDA 011752

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
PRELUDIN×2	BOEHRINGER INGELHEIM	NDA 011752	—	Approved Prior to Jan 1, 1982
PRELUDIN	BOEHRINGER INGELHEIM	NDA 010460	—	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.

Phenmetrazine hydrochloride — frequently asked questions

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

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