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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*
  • Orange Book: Approved Drug Products with Therapeutic Equivalence . . .
    Search by Route of Administration (for example: ORAL) Find Patent Information Search by Patent Number View Newly Added Patents or Delisted Patents Contact Us The Orange Book downloadable data files are updated monthly We make every effort to prevent errors and discrepancies in the Approved Drug Products data files
  • Review - accessdata. fda. gov
    A review of other eltrombopag labelings (NDAs and ANDAs) No safety information not included in the proposed labeling for eltrombopag choline was identified Review of Orange Book for outstanding exclusivities for eltrombopag, identifying one outstanding exclusivity – ODE-210, which expires November 16, 2025
  • SEROQUEL® (quetiapine fumarate) Tablets - Food and Drug Administration
    SEROQUEL® (quetiapine fumarate) Tablets ITEM 13: Pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, the attached information is made of record
  • Nubeqa (darolutamide) Tablets - 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
  • Nexplanon (etonogestrel) implant
    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 (semaglutide) injection - 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
  • Obeticholic Acid Tablets - Food and Drug Administration
    The RLD upon which you have based your ANDA, Intercept’s Ocaliva Tablets, 5 mg and 10 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
  • Review - Food and Drug Administration
    If you identify a listed drug solely to comply with this regulatory requirement, you must provide an appropriate patent certification or statement for any patents that are listed in the Orange Book for the pharmaceutically equivalent product, but you are not required to establish a “bridge” to justify the scientific appropriateness of
  • Spravato (esketamine) nasal spray
    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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