APPLICATION
ANDA073122
TYPE
ANDA
ORIGINAL APPROVAL
1991-08-30
LATEST ACTION
2016-12-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG · CAPSULE · ORAL
Approval history
2016-12-05Labeling · Supplement 19 · standardAP
2000-09-18Manufacturing (CMC) · Supplement 18AP
1999-08-16Manufacturing (CMC) · Supplement 16AP
1998-12-09Manufacturing (CMC) · Supplement 15AP
1998-03-17Manufacturing (CMC) · Supplement 14AP
1996-12-27Manufacturing (CMC) · Supplement 12AP
1996-12-27Labeling · Supplement 10AP
1996-12-27Manufacturing (CMC) · Supplement 9AP
1996-08-28Manufacturing (CMC) · Supplement 13AP
1994-07-18Manufacturing (CMC) · Supplement 8AP
1994-05-27Manufacturing (CMC) · Supplement 5AP
1994-03-16Manufacturing (CMC) · Supplement 6AP
1994-03-16Manufacturing (CMC) · Supplement 7AP
1993-12-02Manufacturing (CMC) · Supplement 3AP
1993-08-20Manufacturing (CMC) · Supplement 2AP
1993-08-20Manufacturing (CMC) · Supplement 1AP
1991-08-30OriginalAP
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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