Assyro AI

Orange Book product · Generic (ANDA)

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

Generic (ANDA)ANDA 088989DISCN ROXANE

At a glance

Apr 26, 1985

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 26, 1985

    41 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROCAINAMIDE HYDROCHLORIDE

Strength

250MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 088989

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.