Subpart C—Abbreviated Applications

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 314
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9. Subpart C

Sections

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