Piroxicam

ANDA 74103, held by Teva Pharms. Piroxicam.

As of Nov 15, 2026, ANDA 74103 (Piroxicam), held by Teva Pharms, was first approved by FDA on Aug 28, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 28, 1992
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
Aug 28, 1992	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


Mar 23, 1999	Supplement 5Manufacturing	Approved	None posted
May 31, 1996	Supplement 4Manufacturing	Approved	None posted
Jul 8, 1994	Supplement 1Manufacturing	Approved	None posted
Nov 5, 1993	Supplement 2Manufacturing	Approved	None posted
Nov 5, 1993	Supplement 3Labeling	Approved	None posted
Aug 28, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74103
Drugs@FDA: Overview at FDA
Company: Teva 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