Piroxicam

Relieves osteoarthritis. ANDA 206152, held by Micro Labs. Piroxicam.

As of Nov 15, 2026, ANDA 206152 (Piroxicam), held by Micro Labs, was first approved by FDA on Dec 29, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Piroxicam capsule is indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam capsule, is 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)

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
Dec 29, 2017	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


Oct 8, 2026	Supplement 8Manufacturing	Approved	None posted
Jul 31, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Feb 3, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Feb 3, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 7, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 29, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206152
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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