APPLICATION
NDA019860
TYPE
NDA
ORIGINAL APPROVAL
1989-11-22
LATEST ACTION
2019-03-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IMODIUM A-D · ReferenceOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2013-02-21Manufacturing (CMC) · Supplement 31 · standardAP
2000-09-26Manufacturing (CMC) · Supplement 19 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 17 · standardAP
1999-11-29Manufacturing (CMC) · Supplement 16 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 15 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 13 · standardAP
1997-02-06Manufacturing (CMC) · Supplement 12 · standardAP
1995-03-22Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-02Manufacturing (CMC) · Supplement 9 · standardAP
1995-02-02Manufacturing (CMC) · Supplement 7 · standardAP
1995-02-02Manufacturing (CMC) · Supplement 8 · standardAP
1994-08-15Labeling · Supplement 10 · standardAP
1994-01-03Manufacturing (CMC) · Supplement 11 · standardAP
1993-07-06Manufacturing (CMC) · Supplement 5 · standardAP
1992-11-23Labeling · Supplement 4AP
1992-01-06Manufacturing (CMC) · Supplement 2 · standardAP
1991-07-25Labeling · Supplement 1AP
1989-11-22Type 3 - New Dosage Form · Original · standardAP
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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