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LOPERAMIDE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON RESEARCH · Approved 2023-01-26

Drug application

FDA Application #
ANDA216876
Application type
Abbreviated New Drug Application (Generic)
Brand name
LOPERAMIDE HYDROCHLORIDE
Generic name
LOPERAMIDE HYDROCHLORIDE
Active ingredients
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
RUBICON RESEARCH
Manufacturer
Advagen Pharma Ltd.,
First approval
2023-01-26

Source

Authoritative
Drugs@FDA application overview
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