Is Amrix still available?

Yes. Amrix (NDA 021777) is listed with marketing status Prescription in the FDA Orange Book.

Does Amrix have a generic?

Yes. The Orange Book lists 23 approved generic (ANDA) applications sharing Amrix's active ingredient (Cyclobenzaprine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Amrix's TE code AB mean?

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

What is Amrix's FDA application number?

Amrix is approved under NDA 021777, held by Teva Pharms Intl.

Orange Book product · Brand (NDA)

Amrix

Cyclobenzaprine Hydrochloride

Brand (NDA)NDA 021777TE ABRLD Teva Pharms Intl

Approved

Feb 01, 2007

Application

Brand (NDA)

TE code

Listed patents

Amrix (Cyclobenzaprine Hydrochloride) is Teva Pharms Intl's brand-name drug, approved by the FDA under NDA 021777 in 2007. 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. 23 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.
Feb 01, 2007
19 yr 9 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Strength

30MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 021777

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 021777

15MGCAPSULE, EXTENDED RELEASE

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 Cyclobenzaprine 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.

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

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