FDA Approved: LOPERAMIDE HYDROCHLORIDE — Supplemental Application (Aurohealth LLC)

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Summary

FDA approved a supplemental application for loperamide hydrochloride from Aurohealth LLC under ANDA206548, confirming the regulatory status of the product.

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Diseases / indications

• Diarrhea
• Irritable Bowel Syndrome with Diarrhea
• Traveler Diarrhea

Drugs mentioned

• Loperamide hydrochloride (LOPERAMIDE HYDROCHLORIDE)

Snippet

SUPPL AP for LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)