APPLICATION
ANDA072993
TYPE
ANDA
ORIGINAL APPROVAL
1992-08-28
LATEST ACTION
2016-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG · CAPSULE · ORAL
Approval history
2016-11-03Labeling · Supplement 13 · standardAP
2001-11-06Manufacturing (CMC) · Supplement 9AP
2000-07-12Manufacturing (CMC) · Supplement 7AP
2000-07-12Manufacturing (CMC) · Supplement 8AP
1999-05-05Manufacturing (CMC) · Supplement 5AP
1997-08-08Manufacturing (CMC) · Supplement 4AP
1996-09-17Manufacturing (CMC) · Supplement 3AP
1996-07-10Labeling · Supplement 2AP
1994-01-24Manufacturing (CMC) · Supplement 1AP
1992-08-28OriginalAP
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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