APPLICATION
ANDA076497
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-10
LATEST ACTION
2021-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2021-04-02Labeling · Supplement 7 · standardAP
2015-09-09Labeling · Supplement 2AP
2003-06-10OriginalAP
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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