MedPath

Piroxicam

Generic Name
Piroxicam
Brand Names
Feldene
Drug Type
Small Molecule
Chemical Formula
C15H13N3O4S
CAS Number
36322-90-4
Unique Ingredient Identifier
13T4O6VMAM

Overview

A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.

Indication

For treatment of osteoarthritis and rheumatoid arthritis.

Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Osteoarthritis (OA)
  • Rheumatoid Arthritis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/24
Not Applicable
Completed
Federal Teaching Hospital Abakaliki
2024/12/11
Phase 3
Not yet recruiting
2024/05/08
Phase 3
Recruiting
Riadh Boukef
2023/02/10
Phase 2
Recruiting
2022/08/05
Phase 4
Completed
Farjad Zafar
2021/11/03
Phase 1
Completed
Nanoform Finland Plc
2019/10/11
Phase 2
Completed
2019/08/20
Early Phase 1
Completed
2019/06/26
Not Applicable
UNKNOWN
2018/11/19
Not Applicable
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Vensun Pharmaceuticals, Inc.
42543-114
ORAL
10 mg in 1 1
3/2/2018
Teva Pharmaceuticals USA, Inc.
0093-0756
ORAL
10 mg in 1 1
2/14/2023
PD-Rx Pharmaceuticals, Inc.
72789-210
ORAL
10 mg in 1 1
2/13/2023
DIRECT RX
61919-188
ORAL
20 mg in 1 1
1/21/2020
Zydus Lifesciences Limited
70771-1429
ORAL
10 mg in 1 1
10/4/2023
Unichem Pharmaceuticals (USA), Inc.
29300-256
ORAL
20 mg in 1 1
4/19/2023
Proficient Rx LP
71205-032
ORAL
20 mg in 1 1
12/1/2018
Quality Care Products, LLC
55700-697
ORAL
20 mg in 1 1
11/21/2018
Bryant Ranch Prepack
71335-9622
ORAL
20 mg in 1 1
12/6/2022
Greenstone LLC
59762-0140
ORAL
10 mg in 1 1
2/2/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ROSIDEN INJECTION 20 mg/ml
SIN06575P
INJECTION
20 mg/ml
9/16/1991
ROSIDEN CAPSULE 20 mg
SIN06131P
CAPSULE
20 mg
5/22/1991
ROSIDEN GEL
SIN05100P
GEL
5 mg/g
10/3/1990
APO-PIROXICAM CAPSULE 10 mg
SIN05491P
CAPSULE
10 mg
2/8/1991
ROXIFEN GEL 500 mg/100 g
SIN10968P
GEL
500 mg/100 g
6/5/1999
APO-PIROXICAM CAPSULE 20 mg
SIN05893P
CAPSULE
20 mg
5/22/1991
BREXIN TABLET 20 mg
SIN07791P
TABLET
20 mg
7/15/1994

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Piroxicam Liniment
国药准字H10980221
化学药品
搽剂
5/9/2020
Piroxicam Liniment
国药准字H10960205
化学药品
搽剂
3/9/2020
Piroxicam Ointment
国药准字H20067365
化学药品
软膏剂
5/14/2020
Piroxicam Ointment
国药准字H20055396
化学药品
软膏剂
2/3/2021
Piroxicam Ointment
国药准字H20054476
化学药品
软膏剂
3/5/2020
Piroxicam Ointment
国药准字H10950046
化学药品
软膏剂
4/21/2020
Piroxicam Capsules
国药准字H44025139
化学药品
胶囊剂
2/23/2020
Piroxicam Capsules
国药准字H44023272
化学药品
胶囊剂
5/7/2020
Piroxicam Capsules
国药准字H44024029
化学药品
胶囊剂
3/12/2020
Piroxicam Capsules
国药准字H44021219
化学药品
胶囊剂
4/26/2024

PPB Drug Approvals

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath