Phenylbutazone

ANDA 84339, held by Fosun Pharma. Phenylbutazone.

As of Nov 15, 2026, ANDA 84339 (Phenylbutazone), held by Fosun Pharma, was first approved by FDA on Jan 10, 1980, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1980
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
Jan 10, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenylbutazone100MG · tablet;oral	Phenylbutazone	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 19, 1986	Supplement 29Manufacturing	Approved	None posted
Dec 19, 1986	Supplement 28Manufacturing	Approved	None posted
Dec 19, 1986	Supplement 27Manufacturing	Approved	None posted
Feb 19, 1986	Supplement 26Manufacturing	Approved	None posted
Feb 19, 1986	Supplement 25Manufacturing	Approved	None posted
Sep 14, 1984	Supplement 22Manufacturing	Approved	None posted
Sep 14, 1984	Supplement 20Manufacturing	Approved	None posted
Jan 10, 1984	Supplement 21Manufacturing	Approved	None posted
Dec 23, 1982	Supplement 18Manufacturing	Approved	None posted
Oct 22, 1982	Supplement 16Manufacturing	Approved	None posted
Aug 26, 1982	Supplement 14Manufacturing	Approved	None posted
Jan 10, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 84339
Drugs@FDA: Overview at FDA
Company: Fosun Pharma

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