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GUIDANCE DOCUMENT

General Guidelines for OTC Combination Products November 1978

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document announces the availability of a guideline that states in detail the agency policy for combining two or more safe and effective OTC active drug ingredients.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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