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U.S. Code Regulations Constitution Journal Apps
  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i4
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 314
    PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
  5. subpart C
    Subpart C—Abbreviated Applications

Subpart C. Subpart C—Abbreviated Applications

  • § 314.92 - Drug products for which abbreviated applications may be submitted.
  • § 314.93 - Petition to request a change from a listed drug.
  • § 314.94 - Content and format of an ANDA.
  • § 314.95 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
  • § 314.96 - Amendments to an unapproved ANDA.
  • § 314.97 - Supplements and other changes to an approved ANDA.
  • § 314.98 - Postmarketing reports.
  • § 314.99 - Other responsibilities of an applicant of an ANDA.
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