APPLICATION
ANDA073079
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-30
LATEST ACTION
1998-10-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SOLUTION · ORAL
Approval history
1998-10-14Manufacturing (CMC) · Supplement 7AP
1998-03-09Labeling · Supplement 5AP
1996-08-28Manufacturing (CMC) · Supplement 4AP
1993-03-29Labeling · Supplement 2AP
1993-03-29Manufacturing (CMC) · Supplement 1AP
1992-04-30OriginalAP
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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