Rifampin

ANDA 65390, held by Chartwell Molecular. Rifampin.

First approved: Mar 28, 2008
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 28, 2008	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Rifampin150MG · capsule;oral	Rifampin	Rx
Rifampin300MG · capsule;oral	Rifampin	Rx

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 16, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Jul 21, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Jan 19, 2022	Supplement 20Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Sep 2, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jun 27, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Jun 15, 2011	Supplement 4Labeling	Approved	None posted
Mar 28, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65390
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters