1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter D - DRUGS FOR HUMAN USE
  5. Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
  6. 21 CFR Subpart C
21 CFR Subpart C
Abbreviated Applications
June 25, 2020
§
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
§
314.92
Drug products for which abbreviated applications may be submitted
§
314.93
Petition to request a change from a listed drug
§
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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Subpart B Applications
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Subpart D FDA Action on Applications and Abbreviated Applications

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