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FDA ANDA · ANDA209837

ANTI DIARRHEAL ANTI GAS

loperamide hydrochloride, simethicone

Sponsor: PERRIGO R AND D

APPLICATION
ANDA209837
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-05
LATEST ACTION
2021-07-09
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

2021-07-09Labeling · Supplement 9 · standardAP
2019-12-03Labeling · Supplement 4 · standardAP
2018-09-05UNKNOWN · 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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