Is Anafranil still available?

Yes. Anafranil (NDA 019906) is listed with marketing status Prescription in the FDA Orange Book.

Does Anafranil have a generic?

Yes. The Orange Book lists 21 approved generic (ANDA) applications sharing Anafranil's active ingredient (Clomipramine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Anafranil's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Anafranil substitutable for its reference brand with no expected difference in clinical effect.

What is Anafranil's FDA application number?

Anafranil is approved under NDA 019906, held by Specgx LLC.

Orange Book product · Brand (NDA)

Anafranil

Clomipramine Hydrochloride

Brand (NDA)NDA 019906TE ABRLD Specgx LLC

Approved

Dec 29, 1989

Application

Brand (NDA)

TE code

Listed patents

Anafranil (Clomipramine Hydrochloride) is Specgx LLC's brand-name drug, approved by the FDA under NDA 019906 in 1989. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 21 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 29, 1989
37 yr 1 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

CLOMIPRAMINE HYDROCHLORIDE

Strength

50MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 019906

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 019906

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Clomipramine Hydrochloride 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.

Anafranil — 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 Clomipramine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo