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FDA Orange Book · active-ingredient family

Selegiline hydrochloride

Selegiline hydrochloride is approved as 3 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZELAPAR · NDA 021479

3

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
ZELAPARRLDBAUSCHNDA 021479—Jun 14, 2006
ELDEPRYLRLDQUAGENNDA 020647—May 15, 1996
SELEGILINE HYDROCHLORIDERLDQUAGENNDA 019334—Jun 05, 1989

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
SELEGILINE HYDROCHLORIDERISINGANDA 206803ABApr 02, 2019
SELEGILINE HYDROCHLORIDELANNETT CO INCANDA 075145—Sep 15, 2003
SELEGILINE HYDROCHLORIDEAPOTEXANDA 075321ABDec 04, 1998
SELEGILINE HYDROCHLORIDENOVITIUM PHARMAANDA 075352ABNov 30, 1998
SELEGILINE HYDROCHLORIDECOSETTEANDA 074756—Nov 25, 1998
SELEGILINE HYDROCHLORIDEKENTONANDA 074912—Apr 30, 1998
SELEGILINE HYDROCHLORIDENOVITIUM PHARMAANDA 074866—Nov 26, 1997
SELEGILINE HYDROCHLORIDEAPOTEXANDA 074871ABJun 06, 1997
SELEGILINE HYDROCHLORIDEI3 PHARMSANDA 074672ABApr 01, 1997
SELEGILINE HYDROCHLORIDECOSETTEANDA 074744—Jan 27, 1997
SELEGILINE HYDROCHLORIDECHARTWELL MOLECULESANDA 074565—Aug 02, 1996
SELEGILINE HYDROCHLORIDECHARTWELL MOLECULESANDA 074641—Aug 02, 1996
SELEGILINE HYDROCHLORIDEG AND W LABS INCANDA 074537—Aug 02, 1996

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.

Selegiline hydrochloride — 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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