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Orange Book product · Generic (ANDA)

TIZANIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE

Generic (ANDA)ANDA 213798RX RUBICON RESEARCH
View TIZANIDINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 28, 2025

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 28, 2025

    10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIZANIDINE HYDROCHLORIDE

Strength

EQ 8MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 213798

Product number

004

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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

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