Piroxicam

ANDA 73536, held by Sun Pharm Industries. Piroxicam.

As of Nov 15, 2026, ANDA 73536 (Piroxicam), held by Sun Pharm Industries, was first approved by FDA on Mar 12, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1993
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
Mar 12, 1993	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Sep 2, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Mar 17, 2006	Supplement 14Labeling	Approved	None posted
May 16, 2000	Supplement 4Manufacturing	Approved	None posted
May 16, 2000	Supplement 5Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 3Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 2Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 1Manufacturing	Approved	None posted
Mar 12, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73536
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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