Sulfamethoxazole

ANDA 85844, held by Rising. Sulfamethoxazole.

As of Nov 15, 2026, ANDA 85844 (Sulfamethoxazole), held by Rising, was first approved by FDA on Mar 23, 1978, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1978
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 23, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfamethoxazole500MG · tablet;oral	Sulfamethoxazole	Discontinued

All 13 submissions, including labeling and manufacturing supplements


May 11, 1984	Supplement 50Manufacturing	Approved	None posted
May 11, 1984	Supplement 49Manufacturing	Approved	None posted
Nov 23, 1983	Supplement 48Manufacturing	Approved	None posted
Nov 23, 1983	Supplement 47Manufacturing	Approved	None posted
Feb 23, 1983	Supplement 44Manufacturing	Approved	None posted
Feb 23, 1983	Supplement 43Manufacturing	Approved	None posted
May 19, 1982	Supplement 41Manufacturing	Approved	None posted
May 19, 1982	Supplement 40Manufacturing	Approved	None posted
May 19, 1982	Supplement 39Manufacturing	Approved	None posted
May 19, 1982	Supplement 38Manufacturing	Approved	None posted
May 19, 1982	Supplement 36Manufacturing	Approved	None posted
May 10, 1982	Supplement 42Manufacturing	Approved	None posted
Mar 23, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85844
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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