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Guidance on Ensulizole, Hypromellose, Meradimate Labeling

06/03/2003
Federal Register Notice: FDA is making available a guidance for industry entitled Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate--Labeling Enforcement Policy. This guidance explains that the agency intends to exercise enforcement discretion by not initiating any enforcement action, until 9/1/03, based on a firm's failure to bring its products' labeling into compliance with the USP monograph title changes. To download this guidance, click here. To view this notice, click here.

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