APPLICATION
ANDA073254
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2000-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2000-09-21Manufacturing (CMC) · Supplement 10AP
1999-08-16Manufacturing (CMC) · Supplement 9AP
1998-03-09Labeling · Supplement 8AP
1996-08-26Manufacturing (CMC) · Supplement 7AP
1996-02-28Labeling · Supplement 5AP
1996-02-28Manufacturing (CMC) · Supplement 6AP
1995-07-25Manufacturing (CMC) · Supplement 3AP
1994-08-30Manufacturing (CMC) · Supplement 4AP
1994-05-27Manufacturing (CMC) · Supplement 2AP
1993-07-30OriginalAP
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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