Abbreviated Applications

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Applications for FDA Approval to Market a New Drug
  7. Abbreviated Applications

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Section
314.92

Drug products for which abbreviated applications may be submitted.

Section
314.93

Petition to request a change from a listed drug.

Section
314.94

Content and format of an ANDA.

Section
314.95

Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

Section
314.96

Amendments to an unapproved ANDA.

Section
314.97

Supplements and other changes to an approved ANDA.

Section
314.98

Postmarketing reports.

Section
314.99

Other responsibilities of an applicant of an ANDA.