Rifampin

ANDA 64217, held by Hikma. Rifampin.

First approved: Oct 29, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 29, 1999	Original application	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rifampin600MG/VIAL · injectable;injection	Rifampin	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 6, 2025	Supplement 17Labeling · Standard review	Approved	None posted
May 6, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jun 13, 2011	Supplement 10Labeling	Approved	None posted
Jan 29, 2001	Supplement 2Labeling	Approved	None posted
Sep 29, 2000	Supplement 1Labeling	Approved	None posted
Oct 29, 1999	Original application	Approved	Letter Label Review

Identifiers

Application: ANDA 64217
Drugs@FDA: Overview at FDA
Company: Hikma

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