Phenylbutazone

ANDA 88994, held by Sun Pharm Industries. Phenylbutazone.

As of Nov 15, 2026, ANDA 88994 (Phenylbutazone), held by Sun Pharm Industries, was first approved by FDA on Dec 4, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1985
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 4, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenylbutazone100MG · capsule;oral	Phenylbutazone	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 15Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 14Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 13Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 10Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 12Manufacturing	Approved	None posted
Nov 20, 1989	Supplement 9Labeling	Approved	None posted
Jun 28, 1989	Supplement 8Labeling	Approved	None posted
Mar 3, 1988	Supplement 6Manufacturing	Approved	None posted
Jul 14, 1987	Supplement 2Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 5Manufacturing	Approved	None posted
Jun 6, 1986	Supplement 3Manufacturing	Approved	None posted
Dec 4, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88994
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