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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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What is otc docket no?
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.
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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.
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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.
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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.
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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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