Is there a generic for Tranylcypromine sulfate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Tranylcypromine sulfate, referencing the brand PARNATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tranylcypromine sulfate?

PARNATE (NDA 012342, ADVANZ PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tranylcypromine sulfate are approved?

Tranylcypromine sulfate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Tranylcypromine sulfate

Tranylcypromine sulfate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PARNATE · NDA 012342

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PARNATERLD	ADVANZ PHARMA	NDA 012342	AB	Aug 16, 1985

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
TRANYLCYPROMINE SULFATE	CROSSMEDIKA SA	ANDA 213503	AB	Jun 27, 2022
TRANYLCYPROMINE SULFATE	NOVITIUM PHARMA	ANDA 206856	AB	Apr 17, 2018
TRANYLCYPROMINE SULFATE	STRIDES PHARMA INTL	ANDA 040640	AB	Jun 29, 2006

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.

Tranylcypromine sulfate — frequently asked questions

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

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