Phenylbutazone

ANDA 86151, held by Watson Labs. Phenylbutazone.

As of Nov 15, 2026, ANDA 86151 (Phenylbutazone), held by Watson Labs, was first approved by FDA on Oct 29, 1979, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1979
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
Oct 29, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenylbutazone100MG · tablet;oral	Phenylbutazone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 22, 1991	Supplement 32Labeling	Approved	None posted
May 10, 1991	Supplement 28Labeling	Approved	None posted
Mar 6, 1989	Supplement 23Labeling	Approved	None posted
May 10, 1988	Supplement 20Labeling	Approved	None posted
Oct 29, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86151
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