Authorized Generic Drug [Food and Drugs] Law and Legal Definition
Pursuant to 21 CFR 314.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 314 Applications for FDA Approval to Market a New Drug; Subpart A General Provisions], Authorized Generic Drug means “a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug.”
Legal Definition list
- Authorized Generic Drug [Food and Drugs]
- Authorized Dispenser [Food and Drugs]
- Authorized Classification Society
- Authorized Account
- Authorization to Sell
- Authorized Individual [Energy]
- Authorized Investigative Agency
- Authorized Medical Physicist
- Authorized Nuclear Pharmacist
- Authorized Nuclear User
- Authorized Officer
Related Legal Terms
- 21st Century Nanotechnology Research and Development Act of 2003
- 3-A Sanitary Standards and Accepted Practice
- 3-Way Incandescent Lamp
- 480th Intelligence, Surveillance and Reconnaissance Wing
- 70th Intelligence, Surveillance and Reconnaissance Wing
- Abandon
- Abandon [Shipping]
- Abandoned Infant
- Abandoned Mark
- Abandoned Mined Lands
