Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-11-17

FDA Approved: LOPERAMIDE HYDROCHLORIDE 2MG — Original Application (MARKSANS PHARMA LIMITED)

View source ↗

Summary

FDA approved Marksans Pharma Limited's loperamide hydrochloride 2 mg tablets as a generic anti-diarrheal under ANDA 220153.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Loperamide hydrochloride 2 mg tablets (Loperamide hydrochloride)

Snippet

ORIG AP for LOPERAMIDE HYDROCHLORIDE 2MG (LOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MG)