APPLICATION
ANDA075232
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-06
LATEST ACTION
2020-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2020-06-08Labeling · Supplement 46 · standardAP
2020-06-08Labeling · Supplement 44 · standardAP
2007-10-23Labeling · Supplement 20AP
2002-10-04Manufacturing (CMC) · Supplement 3AP
2002-10-04Manufacturing (CMC) · Supplement 1AP
2002-10-04Labeling · Supplement 6AP
2002-10-04Labeling · Supplement 4AP
2002-10-04Manufacturing (CMC) · Supplement 2AP
2002-10-04Manufacturing (CMC) · Supplement 5AP
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.