APPLICATION
ANDA064150
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-28
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RIFAMPINPrescription
RIFAMPIN 300MG · CAPSULE · ORAL
RIFAMPINPrescription
RIFAMPIN 150MG · CAPSULE · ORAL
Approval history
2023-08-16Labeling · Supplement 37 · standardAP
2022-01-14Labeling · Supplement 36 · standardAP
2021-09-13Labeling · Supplement 35 · standardAP
2020-08-17Labeling · Supplement 28 · standardAP
2020-08-17Labeling · Supplement 32 · standardAP
2020-08-17Labeling · Supplement 30 · standardAP
2020-08-17Labeling · Supplement 27 · standardAP
2020-08-17Labeling · Supplement 33 · standardAP
2020-08-17Labeling · Supplement 31 · standardAP
2013-07-19Labeling · Supplement 20 · standardAP
2011-06-13Labeling · Supplement 15AP
2005-09-06Labeling · Supplement 11AP
2002-06-28Manufacturing (CMC) · Supplement 7AP
2000-08-09Labeling · Supplement 6AP
2000-02-02Manufacturing (CMC) · Supplement 5AP
1999-03-03Manufacturing (CMC) · Supplement 4AP
1998-05-19Manufacturing (CMC) · Supplement 3AP
1998-01-02Labeling · Supplement 2AP
1998-01-02Manufacturing (CMC) · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.