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OTC Docket No.(s): z08092, z05221, z07046 Term Sheet Version: 143 Document Revision Date: 5/1/2014NONBINDING BUSINESS TERM SHEET TRY AND BUY LICENSE FOR DISCUSSION PURPOSES ONLY Title: Company: Marketing
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OTC docket no is a unique identification number assigned to identify a specific filing with the U.S. Food and Drug Administration's Over-The-Counter (OTC) Drug Establishment Registration database.
Any establishment that manufactures, repacks, or relabels over-the-counter drug products for commercial distribution in the United States is required to file for an OTC docket no.
To fill out the OTC docket no, establishments must complete the required information in the online registration form provided by the FDA's OTC Drug Establishment Registration database.
The purpose of OTC docket no is to provide a means for the FDA to track and monitor over-the-counter drug establishments and their products to ensure compliance with regulatory requirements.
The information that must be reported on the OTC docket no includes establishment name, address, contact information, responsible party details, and a list of all OTC drug products manufactured, repacked, or relabeled by the establishment.
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