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& Juge, N
Dockray GJ
The most robust of these is the New Chemical Entity (NCE) exclusivity, granted to drug products containing an active moiety that has not been previously approved by the agency
This does not make the product FDA-approved and does not remove the need for medical supervision and patient-specific prescriptions
They must have the same active ingredients, be equivalent in strength and dosage, and meet the same standards for safety, purity and effectiveness as the original brand-name product
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