Piroxicam

Relieves osteoarthritis. ANDA 74118, held by Solis Pharms. Piroxicam.

As of Nov 15, 2026, ANDA 74118 (Piroxicam), held by Solis Pharms, was first approved by FDA on Jun 15, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1993
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Piroxicam capsules 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 8 submissions below

Date	Submission	Status	Documents
Jun 15, 1993	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Dec 23, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Dec 23, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Oct 21, 2011	Supplement 3Labeling	Approved	None posted
Sep 14, 2011	Supplement 4Labeling	Approved	None posted
Jun 15, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74118
Drugs@FDA: Overview at FDA
Company: Solis Pharms

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