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  • 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





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