Assyro AI

Orange Book product · Brand (NDA)

IMODIUM

LOPERAMIDE HYDROCHLORIDE

Brand (NDA)NDA 019037DISCN JANSSEN PHARMS
View LOPERAMIDE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jul 31, 1984

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 31, 1984

    42 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LOPERAMIDE HYDROCHLORIDE

Strength

1MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 019037

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.

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