Piroxicam

Relieves osteoarthritis (OA). ANDA 208340, held by Unichem. Piroxicam.

As of Nov 15, 2026, ANDA 208340 (Piroxicam), held by Unichem, was first approved by FDA on Apr 13, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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) 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 5 submissions below

Date	Submission	Status	Documents
Apr 13, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Mar 17, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Feb 21, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Feb 21, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Oct 17, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Apr 13, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208340
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

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