APPLICATION
NDA019037
TYPE
NDA
ORIGINAL APPROVAL
1984-07-31
LATEST ACTION
1987-06-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
IMODIUMDiscontinued
LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SOLUTION · ORAL
Approval history
1987-06-16Labeling · Supplement 3 · standardAP
1986-06-02Manufacturing (CMC) · Supplement 2 · standardAP
1985-10-29Labeling · Supplement 1 · standardAP
1984-07-31Type 3 - New Dosage Form · Original · standardAP
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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