Piroxicam

Relieves osteoarthritis (OA). ANDA 210347, held by Strides Pharma. Piroxicam.

As of Nov 15, 2026, ANDA 210347 (Piroxicam), held by Strides Pharma, was first approved by FDA on Jan 26, 2018, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Piroxicam Capsules are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of osteoarthritis (OA) Relief of the signs and symptoms of rheumatoid arthritis (RA) Piroxicam Capsules are indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 26, 2018	Original application	Approved	None posted

Products

2 strengths and forms


Piroxicam10MG · capsule;oral	Piroxicam	Rx
Piroxicam20MG · capsule;oral	Piroxicam	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Feb 3, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Aug 16, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Aug 16, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Jan 26, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210347
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters