APPLICATION
ANDA074194
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-30
LATEST ACTION
2001-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2001-11-20Labeling · Supplement 8AP
1997-01-24Labeling · Supplement 6AP
1997-01-24Labeling · Supplement 5AP
1995-06-05Labeling · Supplement 4AP
1995-03-01Manufacturing (CMC) · Supplement 2AP
1994-07-01Labeling · Supplement 1AP
1992-10-30OriginalAP
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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