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FDA ANDA · ANDA211438

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA211438
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-17
LATEST ACTION
2021-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG · TABLET · ORAL

Approval history

2021-06-17UNKNOWN · Original · standardAP
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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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