final dosage form
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 379G — for purposes of this subpart (3 versions over time)
The term “final dosage form” means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).
21 U.S.C. § 379J — for purposes of this subpart
The term “final dosage form” means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.
21 U.S.C. § 379j-21 — in this section
The term “final dosage form” means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.
21 U.S.C. § 379j-51 — for purposes of this subpart
The term “final dosage form” means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).