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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Certificate of Pharmaceutical Product - Application Instructions -
Internet:http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm095808.pdf
Origin/Publisher:Division of Labeling and Nonprescription Drug Compliance; Office of Compliance, Center for Drug Evaluation and Research
Content:Application instructions and procedures for the issuance of Certificate of Pharmaceutical Products by the CDER