Friday, July 10, 2026

Drug profile · INN

ranitidine

ranitidine (APO-RANITIDINE) is a histamine h2 receptor antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — ranitidine
US status
approved
Class
Route
ORAL
Patents
0
Programs
3
Data quality
0.84

Quick answer

ranitidine (APO-RANITIDINE) is a histamine h2 receptor antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ranitidine
Brand APO-RANITIDINE
Mechanism Histamine H2 receptor antagonist
Target Histamine H2 receptor
Route ORAL
Formulation SOLUTION

Mechanism of action

Histamine H2 receptor antagonist

Primary target: Histamine H2 receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. KL264-01 Phase 2 · Anaxis Pharma · Metastatic or locally advanced unresectable solid tumors pro
  2. SKB264-II-04 Phase 2 · Anaxis Pharma · Advanced or Metastatic Non-small Cell Lung Cancer
  3. UC_0160/1406 Phase 2 · Ningbo Cancer Hospital · Penis carcinoma

Related & competitor drugs

  1. cimetidine Histamine H2 receptor antagonist
  2. cimetidine hydrochloride Histamine H2 receptor antagonist
  3. famotidine Histamine H2 receptor antagonist
  4. nizatidine Histamine H2 receptor antagonist
  5. ranitidine hydrochloride Histamine H2 receptor antagonist
  6. betazole hydrochloride Histamine H2 receptor agonist

Frequently asked questions

What is ranitidine?

ranitidine (APO-RANITIDINE) is a histamine h2 receptor antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ranitidine?

APO-RANITIDINE is a marketed brand name for ranitidine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ranitidine?

ranitidine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.