Piroxicam

ANDA 74148, held by Ivax Sub Teva Pharms. Piroxicam.

As of Nov 15, 2026, ANDA 74148 (Piroxicam), held by Ivax Sub Teva Pharms, was first approved by FDA on Jun 3, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1996
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 3, 1996	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Apr 8, 2002	Supplement 7Manufacturing	Approved	None posted
Apr 8, 2002	Supplement 6Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 8Manufacturing	Approved	None posted
Jun 8, 2001	Supplement 5Manufacturing	Approved	None posted
Sep 22, 2000	Supplement 2Manufacturing	Approved	None posted
Sep 22, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 4Manufacturing	Approved	None posted
Jun 3, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74148
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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