APPLICATION
ANDA091292
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-20
LATEST ACTION
2021-12-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML · SOLUTION · ORAL
Approval history
2021-12-13Labeling · Supplement 16 · standardAP
2021-12-13Labeling · Supplement 12 · standardAP
2015-11-30Labeling · Supplement 3 · standardAP
2015-11-30Labeling · Supplement 8 · standardAP
2011-05-20OriginalAP
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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