If the NDA applicant is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, use Form FDA 3542a. If the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug after approval of an NDA or supplement, use Form FDA 3542. The agency will not list or publish patent information in the Orange Book if it is not provided on Form FDA 3542.