Assyro AI

Orange Book product · Generic (ANDA)

TIZANIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE

Generic (ANDA)ANDA 211798TE ABRX ALKEM LABS LTD
View TIZANIDINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 25, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 25, 2019

    7 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIZANIDINE HYDROCHLORIDE

Strength

EQ 2MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 211798

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TIZANIDINE HYDROCHLORIDE

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.

Agent CTA Background

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

Book a Demo