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FDA ANDA · ANDA206548

LOPERAMIDE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA206548
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-15
LATEST ACTION
2021-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

LOPERAMIDE HYDROCHLORIDEOver-the-counter
LOPERAMIDE HYDROCHLORIDE 2MG · TABLET · ORAL

Approval history

2021-07-09Labeling · Supplement 8 · standardAP
2021-07-09Labeling · Supplement 6 · standardAP
2021-07-09Labeling · Supplement 3 · standardAP
2021-07-09Labeling · Supplement 11 · standardAP
2019-05-28Manufacturing (CMC) · Supplement 1AP
2015-12-15UNKNOWN · Original · standardAP
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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