APPLICATION
ANDA074091
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-10
LATEST ACTION
2021-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2021-07-09Labeling · Supplement 34 · standardAP
2021-07-09Labeling · Supplement 30 · standardAP
2021-07-09Labeling · Supplement 33 · standardAP
2020-09-09Labeling · Supplement 36 · standardAP
2006-09-12Labeling · Supplement 21AP
2002-10-16Labeling · Supplement 9AP
2002-01-17Manufacturing (CMC) · Supplement 8AP
2000-12-28Labeling · Supplement 5AP
2000-06-21Manufacturing (CMC) · Supplement 7AP
1998-02-27Labeling · Supplement 3AP
1997-05-13Manufacturing (CMC) · Supplement 4AP
1994-07-18Manufacturing (CMC) · Supplement 2AP
1993-06-16Labeling · Supplement 1AP
1992-12-10OriginalAP
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.
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