Assyro AI

Orange Book product · Generic (ANDA)

PARACAINE

PROPARACAINE HYDROCHLORIDE

Generic (ANDA)ANDA 087681DISCN OPTOPICS

At a glance

Aug 05, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 05, 1982

    44 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROPARACAINE HYDROCHLORIDE

Strength

0.5%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 087681

Product number

001

Marketing status

DISCN

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.