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FDA NDA · NDA021855

ANTI-DIARRHEAL

loperamide hydrochloride

Sponsor: BIONPHARMA

APPLICATION
NDA021855
TYPE
NDA
ORIGINAL APPROVAL
2005-08-04
LATEST ACTION
2020-06-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

LOPERAMIDE HYDROCHLORIDE · ReferenceOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · CAPSULE · ORAL
LOPERAMIDE HYDROCHLORIDE · ReferenceOver-the-counter
LOPERAMIDE HYDROCHLORIDE 1MG · CAPSULE · ORAL

Approval history

2020-06-22Labeling · Supplement 14 · standard — Letter ↗AP
2019-01-31Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2017-03-09Labeling · Supplement 6 · standard — Letter ↗AP
2015-12-11Manufacturing (CMC) · Supplement 5 · standardAP
2005-08-04Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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