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FDA NDA · NDA017690

IMODIUM

Sponsor: J AND J CONSUMER INC

APPLICATION
NDA017690
TYPE
NDA
ORIGINAL APPROVAL
1976-12-28
LATEST ACTION
2016-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

IMODIUMDiscontinued
LOPERAMIDE HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2016-11-03Labeling · Supplement 5 · standard — Label ↗AP
1999-06-17Manufacturing (CMC) · Supplement 2 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 4 · standardAP
1992-10-02Manufacturing (CMC) · Supplement 3 · standardAP
1988-04-27Labeling · Supplement 1AP
1976-12-28Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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