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Orange Book product · Generic (ANDA)

TETRACAINE HYDROCHLORIDE

TETRACAINE HYDROCHLORIDE

Generic (ANDA)ANDA 217227TE AB1RX SOMERSET THERAPS LLC

At a glance

Dec 20, 2024

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2024

    1 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TETRACAINE HYDROCHLORIDE

Strength

0.5%

Dosage form

SOLUTION

Route

OPHTHALMIC

TE code

AB1

Application

ANDA 217227

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TETRACAINE 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.