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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-12-14

Drug application

FDA Application #
ANDA211059
Application type
Abbreviated New Drug Application (Generic)
Brand name
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Generic name
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Active ingredients
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Dosage form
TABLET
Route
ORAL
Marketing status
Over-the-counter
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
WALMART INC.
First approval
2020-12-14

Source

Authoritative
Drugs@FDA application overview
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