APPLICATION
ANDA065028
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-14
LATEST ACTION
2015-11-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIFAMPINDiscontinued
RIFAMPIN 300MG · CAPSULE · ORAL
RIFAMPINDiscontinued
RIFAMPIN 150MG · CAPSULE · ORAL
Approval history
2015-11-23Labeling · Supplement 15 · standardAP
2011-06-27Labeling · Supplement 12AP
2004-06-03Labeling · Supplement 4AP
2002-08-20Labeling · 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.