Is Amitriptyline Hydrochloride still available?

Yes. Amitriptyline Hydrochloride (ANDA 085968) is listed with marketing status Prescription in the FDA Orange Book.

What is Amitriptyline Hydrochloride a generic of?

Amitriptyline Hydrochloride is a generic (ANDA 085968) containing Amitriptyline Hydrochloride. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Amitriptyline Hydrochloride's TE code AB mean?

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

What is Amitriptyline Hydrochloride's FDA application number?

Amitriptyline Hydrochloride is approved under ANDA 085968, held by Sandoz.

Orange Book product · Generic (ANDA)

Amitriptyline Hydrochloride

Generic (ANDA)ANDA 085968TE ABRLD Sandoz

Approved

Approved Prior to Jan 1, 1982

Application

Generic (ANDA)

TE code

Listed patents

Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) is a generic drug approved under an ANDA (085968), marketed by Sandoz. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand.

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

AMITRIPTYLINE HYDROCHLORIDE

Strength

25MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 085968

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 085968

Brand + generics

Active-ingredient family

Generic (ANDA) of Amitriptyline Hydrochloride

View full Amitriptyline 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.

Amitriptyline Hydrochloride — 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 Amitriptyline 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