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Orange Book product · Generic (ANDA)

PROPARACAINE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE

Generic (ANDA)ANDA 215816TE ATRX SOMERSET THERAPS LLC

At a glance

Aug 09, 2024

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 09, 2024

    1 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROPARACAINE HYDROCHLORIDE

Strength

0.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 215816

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PROPARACAINE 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.