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Theophylline cough/cold products barred from sale after January 1996 -- FDA final rule.

This article was originally published in The Tan Sheet

Executive Summary

THEOPHYLLINE-CONTAINING OTC COUGH/COLD PRODUCTS BARRED FROM SALE after Jan. 29, 1996 under a final rule issued by FDA on July 27. The rule establishes that OTC cough/cold combination drug products containing theophylline are Category II (not safe and effective) and misbranded. "Therefore," the agency stated, "on or after Jan. 29, 1996, no OTC cough/cold combination drug products containing theophylline may be initially introduced or initially delivered into interstate commerce unless they are the subject of an approved application."
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