Listed drug

Listed drug means a new drug product that has an effective approval under section 505 of the act for safety and effectiveness or under section 505(j) of the act, which has not been withdrawn or suspended under section 505(e)(1) through (e)(5) or (j)(5) of the act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by the drug product's identification as a drug with an effective approval in the current edition of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the list) or any current supplement thereto, as a drug with an effective approval. A drug product is deemed to be a listed drug on the date of effective approval of the application or abbreviated application for that drug product.

Source

21 CFR § 314.3

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Scoping language

The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part.

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