Is there a generic for Prazepam?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Prazepam, referencing the brand CENTRAX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Prazepam?

CENTRAX (NDA 018144, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Prazepam are approved?

Prazepam is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Prazepam

Prazepam is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CENTRAX · NDA 018144

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, tablet

Product	Applicant	Application	TE	Approved
CENTRAX×3	PARKE DAVIS	NDA 018144	—	Approved Prior to Jan 1, 1982
CENTRAX	PARKE DAVIS	NDA 017415	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PRAZEPAM	USL PHARMA	ANDA 070427	—	Nov 06, 1987
PRAZEPAM	USL PHARMA	ANDA 070428	—	Nov 06, 1987

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.

Prazepam — frequently asked questions

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

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