Hydroxyzine Hydrochloride - Food and Drug Administration Recommended studies: Hydroxyzine Hydrochloride Tablets are a DESI1 effective drug for which there are no known or suspected bioequivalence problems, and as such is rated “AA” in the FDA CDER’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”)
Phentermine Hydrochloride - Food and Drug Administration Phentermine Hydrochloride is a DESI1 effective drug for which there are no known or suspected bioequivalence problems, and as such is rated “AA” in the FDA CDER’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”)
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate - Food and Drug . . . Recommended studies: Acetaminophen; Caffeine: Dihydrocodeine bitartrate Tablets are a DESI1 effective drug for which there are no known or suspected bioequivalence problems, and as such is rated “AA” in the FDA CDER’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”)
Brukinsa (zanubrutinib) capsules - Food and Drug Administration Please refer to your supplemental new drug application (sNDA) dated and received May 22, 2024, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Brukinsa (zanubrutinib) capsules
Zoryve (roflumilast) cream - Food and Drug Administration Pursuant to 21 CFR 314 53(d)(2) and 314 70(f), certain changes to an approved NDA submitted in a supplement require you to submit patent information for listing in the Orange Book upon approval of the supplement
Ozempic (semglutide) injection Pursuant to 21 CFR 314 53(d)(2) and 314 70(f), certain changes to an approved NDA submitted in a supplement require you to submit patent information for listing in the Orange Book upon approval of the supplement
Orange Book Data File Download Instructions Orange Book Data File Download Instructions A step-by-step guide to download the latest Orange Book monthly data to Microsoft Excel on Microsoft Windows*
Acetaminophen; Codeine phosphate - Food and Drug Administration Recommended Studies: Acetaminophen; Codeine Phosphate Tablet is TE-coded “AA” in the FDA CDER’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”), which indicates that there are no known or suspected bioequivalence problems for Acetaminophen; Codeine Phosphate Tablets Pursuant to Section 21 CFR § 320 22 (c), the waiver of in vivo BE study requirements
Wegovy (semaglutide) Please refer to your supplemental new drug applications (sNDAs) dated and received January 5, 2026, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection and Wegovy (semaglutide) tablets
Rybelsus (semaglutide) tablets Pursuant to 21 CFR 314 53(d)(2) and 314 70(f), certain changes to an approved NDA submitted in a supplement require you to submit patent information for listing in the Orange Book upon approval of the supplement