Assyro AI

Orange Book product · Generic (ANDA)

CIMETIDINE HYDROCHLORIDE

CIMETIDINE HYDROCHLORIDE

Generic (ANDA)ANDA 074428DISCN PH HEALTH

At a glance

Apr 25, 1996

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 25, 1996

    30 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CIMETIDINE HYDROCHLORIDE

Strength

EQ 300MG BASE/2ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 074428

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CIMETIDINE 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.