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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 314 - Applications for FDA Approval to Market a New Drug |
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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. |