Assyro AI

Orange Book product · Generic (ANDA)

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

Generic (ANDA)ANDA 088531DISCN SMITH AND NEPHEW
View PROCAINAMIDE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 04, 1985

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 04, 1985

    41 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROCAINAMIDE HYDROCHLORIDE

Strength

500MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 088531

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PROCAINAMIDE 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