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Knoll's Vicodin

Executive Summary

Firm is requesting FDA to include the high strength 7.5 mg hydrocodone bitartrate/750 mg acetaminophen tab on the ANDA suitable list. The 5 mg hydrocodone bitartrate/500 mg acetaminophen dosage is currently listed. Knoll notes that the usual dose of Extra-Strength Tylenol is two 500 mg tabs of acetaminophen three or four times daily.
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PS008201

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