Wednesday, July 8, 2026

Drug profile · INN

diclofenac sodium

diclofenac sodium (DICLOFENAC SODIUM) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — diclofenac sodium
US status
approved
Class
Route
OPHTHALMIC
Patents
0
Programs
8
Data quality
0.89

Quick answer

diclofenac sodium (DICLOFENAC SODIUM) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN diclofenac sodium
Brand DICLOFENAC SODIUM
Mechanism Cyclooxygenase inhibitor
Target Cyclooxygenase
Route OPHTHALMIC
Formulation SOLUTION

Mechanism of action

Cyclooxygenase inhibitor

Primary target: Cyclooxygenase

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Diclofenac Sodium Topical Gel, 1% Phase 3 · Amneal Pharma Europe · Osteoarthritis
  2. Diclofenac sodium Phase 3 · Teva Pharma · Actinic Keratosis
  3. compound diclofenac sodium Phase 2 · First People's Hospital · Acute Abdominal Pain
  4. 400314 Phase 1 · Haleon - Gebro · For the local, symptomatic treatment of pain in acute bruise
  5. 300128 Approved · Haleon - Gebro · Mild/non-serious osteoarthritis (OA) of the knee.
  6. Klisyri 10 mg/g ointment, Solaraze 30 mg/g Gel Approved · ALMIRALL S.P.A · Actinic Keratosis
  7. diclofenac sodium topical gel Approved · Teva Pharma · Multiple Sclerosis
  8. Topical diclofenac sodium gel Unknown · Chinese Academy of · Hand Osteoarthritis

Related & competitor drugs

  1. aspirin Cyclooxygenase inhibitor
  2. bromfenac sodium Cyclooxygenase inhibitor
  3. diclofenac potassium Cyclooxygenase inhibitor
  4. diflunisal Nervous system (N02)
  5. fenoprofen calcium Cyclooxygenase inhibitor
  6. flurbiprofen Cyclooxygenase inhibitor

Frequently asked questions

What is diclofenac sodium?

diclofenac sodium (DICLOFENAC SODIUM) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for diclofenac sodium?

DICLOFENAC SODIUM is a marketed brand name for diclofenac sodium. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of diclofenac sodium?

diclofenac sodium 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.