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FDA ANDA · ANDA220100
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride oral
Sponsor: BIONPHARMA
APPLICATION
ANDA220100
TYPE
ANDA
ORIGINAL APPROVAL
2025-09-19
LATEST ACTION
2025-09-19
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML · SOLUTION · ORAL
Approval history
2025-09-19UNKNOWN · 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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