List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

  • To improve transparency and encourage the development and submission of  ANDAs in markets with limited competition
  • Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion
  • Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA


Image credit: FDA

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