Assyro AI

Orange Book product · Brand (NDA)

PROPULSID

CISAPRIDE MONOHYDRATE

Brand (NDA)NDA 020398DISCN JANSSEN PHARMS

At a glance

Sep 15, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 1995

    31 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CISAPRIDE MONOHYDRATE

Strength

EQ 1MG BASE/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 020398

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.