Piroxicam

ANDA 74102, held by Pharmobedient. Piroxicam.

As of Nov 15, 2026, ANDA 74102 (Piroxicam), held by Pharmobedient, was first approved by FDA on Jul 31, 1992, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1992
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
Jul 31, 1992	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


Feb 18, 2016	Supplement 13Labeling · Standard review	Approved	None posted
May 8, 2008	Supplement 11Labeling	Approved	None posted
Jul 3, 2006	Supplement 10Labeling	Approved	None posted
Jan 2, 2004	Supplement 7Labeling	Approved	None posted
Feb 5, 1998	Supplement 4Manufacturing	Approved	None posted
Jan 21, 1998	Supplement 3Manufacturing	Approved	None posted
Mar 9, 1994	Supplement 1Manufacturing	Approved	None posted
Jul 31, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74102
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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