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英文字典中文字典相关资料:


  • 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*
  • Lifitegrast Ophthalmic Solution - Food and Drug Administration
    The RLD upon which you have based your ANDA, Novartis’s Xiidra Ophthalmic Solution, 5%, is subject to periods of patent protection The following patents and expiration dates are currently listed in the Agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”): U S Patent Number
  • Linagliptin Tablets - Food and Drug Administration
    The RLD upon which you have based your ANDA, Boehringer’s Tradjenta Tablets, 5 mg, is subject to periods of patent protection The following patents and expiration dates are currently listed in the Agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”): U S Patent Number
  • 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”)
  • CENTER FOR DRUG EVALUATION AND RESEARCH
    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
  • Naropin (ropivacaine hydrochloride) injection - Food and Drug . . .
    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
  • Sodium polystyrene sulfonate Oral and Rectal Suspension
    Sodium polystyrene sulfonate suspension is a Drug Efficacy Study Implementation (DESI) 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 (i e , the “Orange Book”)
  • 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
  • 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
  • Nexplanon - accessdata. fda. gov
    You also must ensure that any changes to your approved NDA that require the submission of a request to remove patent information from the Orange Book are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR 314 53(d)(2)(ii)(B) and 314 53(f)(2)(iv)





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