us-fda-guidance-700bc3b13716ac5b027c0a48d652e577•General Guidelines for OTC Combination Products
General Guidelines for OTC Combination Products
us-fda-guidance-700bc3b13716ac5b027c0a48d652e577General Guidelines for OTC Combination ProductsGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
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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