Piroxicam

ANDA 74460, held by Watson Labs. Piroxicam.

As of Nov 15, 2026, ANDA 74460 (Piroxicam), held by Watson Labs, was first approved by FDA on Sep 29, 1995, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1995
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 29, 1995	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


Apr 12, 2001	Supplement 7Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 5Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 3Manufacturing	Approved	None posted
Jun 16, 1997	Supplement 2Manufacturing	Approved	None posted
Jun 16, 1997	Supplement 1Manufacturing	Approved	None posted
Sep 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74460
Drugs@FDA: Overview at FDA
Company: Watson 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