Phenylbutazone

ANDA 87774, held by Chartwell Rx. Phenylbutazone.

As of Nov 15, 2026, ANDA 87774 (Phenylbutazone), held by Chartwell Rx, was first approved by FDA on Jun 16, 1982, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 16, 1982
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 16, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenylbutazone100MG · capsule;oral	Phenylbutazone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 15, 1985	Supplement 8Manufacturing	Approved	None posted
Dec 22, 1983	Supplement 7Manufacturing	Approved	None posted
Jun 16, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87774
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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