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FDA Orange Book · active-ingredient family

Phenelzine sulfate

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

Reference-listed drug:NARDIL · NDA 011909

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
NARDILRLDPARKE DAVISNDA 011909ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
PHENELZINE SULFATENOVEL LABS INCANDA 200181ABDec 08, 2010

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.

Phenelzine sulfate — frequently asked questions

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

Agent CTA Background

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