APPLICATION
ANDA074352
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-17
LATEST ACTION
2015-02-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SOLUTION · ORAL
Approval history
2015-02-27Manufacturing (CMC) · Supplement 4AP
2001-03-19Labeling · Supplement 2AP
2001-03-19Manufacturing (CMC) · Supplement 1AP
1995-11-17OriginalAP
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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