Administrative Actions on Applications

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Animal Drugs, Feeds, and Related Products
  6. New Animal Drug Applications
  7. Administrative Actions on Applications

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Section
514.80

Records and reports concerning experience with approved new animal drugs.

Section
514.87

Annual reports for antimicrobial animal drug sales and distribution.

Section
514.100

Evaluation and comment on applications.

Section
514.105

Approval of applications.

Section
514.106

Approval of supplemental applications.

Section
514.110

Reasons for refusing to file applications.

Section
514.111

Refusal to approve an application.

Section
514.115

Withdrawal of approval of applications.

Section
514.116

Notice of withdrawal of approval of application.

Section
514.117

Adequate and well-controlled studies.

Section
514.120

Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.

Section
514.121

Service of notices and orders.