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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER D—DRUGS FOR HUMAN USE
  6. PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
  7. Subpart C—Abbreviated Applications

21 CFR Subpart C - Subpart C—Abbreviated Applications

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  1. § 314.92 Drug products for which abbreviated applications may be submitted.
  2. § 314.93 Petition to request a change from a listed drug.
  3. § 314.94 Content and format of an ANDA.
  4. § 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
  5. § 314.96 Amendments to an unapproved ANDA.
  6. § 314.97 Supplements and other changes to an approved ANDA.
  7. § 314.98 Postmarketing reports.
  8. § 314.99 Other responsibilities of an applicant of an ANDA.
Source:
57 FR 17983, Apr. 28, 1992, unless otherwise noted.

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