Phenylbutazone

ANDA 87756, held by Watson Labs. Phenylbutazone.

As of Nov 15, 2026, ANDA 87756 (Phenylbutazone), held by Watson Labs, was first approved by FDA on Dec 17, 1982, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1982
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 17, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenylbutazone100MG · capsule;oral	Phenylbutazone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 22, 1991	Supplement 13Labeling	Approved	None posted
Nov 21, 1991	Supplement 15Labeling	Approved	None posted
May 10, 1991	Supplement 14Labeling	Approved	None posted
Mar 6, 1989	Supplement 12Labeling	Approved	None posted
Dec 17, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87756
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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