← FDA DRUG APPROVALS

FDA NDA · NDA050627

RIFADIN IV

rifampin

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA050627
TYPE
NDA
ORIGINAL APPROVAL
1989-05-25
LATEST ACTION
2025-12-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RIFADIN · ReferencePrescription
RIFAMPIN 600MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-12-05Labeling · Supplement 39 · standard — Letter ↗AP
2025-10-08Labeling · Supplement 38 · standard — Label ↗AP
2024-10-10Labeling · Supplement 37 · standard — Label ↗AP
2023-12-08Labeling · Supplement 36 · standard — Letter ↗AP
2023-08-16Labeling · Supplement 35 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 34 · standard — Letter ↗AP
2023-02-10Labeling · Supplement 33 · standard — Letter ↗AP
2022-01-29Labeling · Supplement 30 · standard — Letter ↗AP
2021-10-21Labeling · Supplement 29 · standard — Label ↗AP
2021-06-17Labeling · Supplement 28 · standard — Letter ↗AP
2020-05-12Labeling · Supplement 27 · standard — Letter ↗AP
2019-08-27Labeling · Supplement 25 · standard — Label ↗AP
2019-02-28Labeling · Supplement 23 · standard — Letter ↗AP
2019-01-23Labeling · Supplement 21 · standard — Label ↗AP
2018-01-08Labeling · Supplement 20 · standard — Label ↗AP
2017-04-24Labeling · Supplement 17 · standard — Label ↗AP
2015-12-02Manufacturing (CMC) · Supplement 16 · standardAP
2015-04-09Manufacturing (CMC) · Supplement 15 · standardAP
2013-02-27Labeling · Supplement 14 · standard — Label ↗AP
2010-11-10Labeling · Supplement 12 · standard — Label ↗AP
2004-08-20Labeling · Supplement 8 · standard — Label ↗AP
2000-04-12Labeling · Supplement 6 · standardAP
2000-04-12Labeling · Supplement 7 · standardAP
1996-09-17Labeling · Supplement 4 · standardAP
1995-07-28Manufacturing (CMC) · Supplement 5 · standardAP
1993-06-18Labeling · Supplement 1AP
1992-03-10Labeling · Supplement 2AP
1989-05-25Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →