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Asta Medica GmbH

This article was originally published in The Tan Sheet

Executive Summary

Petitions FDA on Sept. 3 to allow the filing of an ANDA for an effervescent OTC dosage form of loperamide HCI 1 mg. Asta Medica said its proposed product is identical to McNeil's Imodium A-D in active ingredient, route of administration, strength and safety and effectiveness.
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