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GUIDANCE DOCUMENT

Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy June 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2003-D-0090
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance discusses how FDA plans to exercise its enforcement discretion after September 1, 2002, with regard to drug products whose labeling does not use the established names for ensulizole, hypromellose, meradimate, octinoxate, and octisalate.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0090.

 
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