Rifater

NDA 50705, held by Sanofi Aventis US. Isoniazid; Pyrazinamide; Rifampin.

As of Nov 13, 2026, NDA 50705 (Rifater), held by Sanofi Aventis US, was first approved by FDA on May 31, 1994, with 24 approved supplements and 0 published complete response letters.

First approved: May 31, 1994
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
May 31, 1994	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rifater50MG;300MG;120MG · tablet;oral	Isoniazid; Pyrazinamide; Rifampin	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 5, 2025	Supplement 29Labeling · Standard review	Approved	Label Letter
Oct 8, 2025	Supplement 28Labeling · Standard review	Approved	Label Letter
Feb 5, 2025	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 10, 2024	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 8, 2023	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 16, 2023	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 10, 2023	Supplement 22Labeling · Standard review	Approved	Label Letter
Jan 29, 2022	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 21, 2021	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 17, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
May 12, 2020	Supplement 18Labeling · Standard review	Approved	Label Letter
Aug 27, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 28, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 23, 2019	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 8, 2018	Supplement 12Labeling · Standard review	Approved	Letter Label
Apr 24, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 27, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 12, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 18, 2008	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 28, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Oct 6, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Apr 8, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 8, 1994	Supplement 1Labeling · Standard review	Approved	None posted
May 31, 1994	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 50705
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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