FDA Orange Book

Generic for Eldepryl

Eldepryl contains selegiline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Eldepryl is selegiline. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Eldepryl products in the Orange Book

Eldepryl products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral5MGDiscontinuedNone3AB

NDA 020647, held by QUAGEN PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic selegiline

Approved generic versions of Eldepryl
CompanyANDATE codeApprovedStrengths
NOVITIUM PHARMA LLC075352AB (A-rated, therapeutically equivalent)November 30, 19985MG
APOTEX INC075321AB (A-rated, therapeutically equivalent)December 4, 19985MG
RISING PHARMA HOLDINGS INC206803AB (A-rated, therapeutically equivalent)April 2, 20195MG

Questions

Is there a generic for Eldepryl?

Yes. The generic name for Eldepryl is selegiline. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Eldepryl?

The active ingredient in Eldepryl is selegiline, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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