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  1. FDA’s Labeling Resources for Human Prescription Drugs

Prescribing Information Resources

For Industry

Who is the Audience for This Webpage?

FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs see video. For other prescription drug labeling resources for industry such as those for FDA-approved patient labeling, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs. If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines.

Prescribing Information

Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.


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