Piroxicam

Relieves osteoarthritis. ANDA 206136, held by Strides Pharma. Piroxicam.

As of Nov 15, 2026, ANDA 206136 (Piroxicam), held by Strides Pharma, was first approved by FDA on Jun 20, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Piroxicam capsules, USP are indicated:

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

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
Jun 20, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Piroxicam10MG · capsule;oral	Piroxicam	Discontinued
Piroxicam20MG · capsule;oral	Piroxicam	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Feb 21, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Feb 21, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jul 23, 2018	Supplement 3Manufacturing	Approved	None posted
Jun 20, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206136
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