Is Asendin still available?

Asendin (NDA 018021) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Asendin have a generic?

Yes. The Orange Book lists 6 approved generic (ANDA) applications sharing Asendin's active ingredient (Amoxapine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Asendin's FDA application number?

Asendin is approved under NDA 018021, held by Lederle.

Orange Book product · Brand (NDA)

Asendin

Amoxapine

Brand (NDA)NDA 018021Discontinued Lederle

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Asendin (Amoxapine) is Lederle's brand-name drug, approved by the FDA under NDA 018021. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 6 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

AMOXAPINE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 018021

Product number

003

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 018021

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Amoxapine family

Orange Book patent file

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.

Asendin — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Amoxapine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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