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Quantum doxylamine succinate (Unisom) ANDA

Executive Summary

Quantum received the first generic approval of Pfizer's Unisom 25 mg tabs for use as a sleep aid, net Par Pharmaceuticals as stated in "The Pink Sheet" (July 13, In Brief). The firm's supplemental ANDA for the additional use as a sleep aid was approved on Aug. 2, 1985. Copley Pharmaceuticals followed with a supplemental ANDA approval in 1986. The drug has also been approved through ANDAs as an antihistamine for use in OTC cough/cold products.
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PS012255

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