reference listed drug


Also found in: Acronyms.

reference listed drug

An approved drug product to which new generic versions are compared to show bioequivalence. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application.

By designating a single reference-listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand-name counterpart.
References in periodicals archive ?
147) Under that previous mechanism, an ANDA applicant proposed a generic product with labeling that differs from that of the reference listed drug, and the applicant argued to the FDA that the proposed labeling rendered the drug as safe and effective as the concurrently approved labeling of the listed drug.
Losartan Potassium Tablets, 25mg and 50mg, an FDA-approved generic version of the reference listed drug, Cozaar from Merck, which is also indicated for the treatment of hypertension.
What are the differences in the container closure system(s) between this product and the Reference Listed Drug (RLD)?
Additionally, the company has passed the US FDA approval for its ANDA for Lansoprazole Delayed-Release Capsules USP in 15 mg (OTC), which the bioequivalent to the reference listed drug, Prevacid 24HR Delayed-Release Capsules, 15 mg, of GlaxoSmithKline.
The Reference Listed Drug at the FDA is Bristol-Myers Squibb's Glucophage[R] product ([metformin hydrochloride] Tablets).
The company said the Oxycodone and Acetaminophen Tablets, USP in 5 mg/325 mg and 10 mg/325 mg is the therapeutic equivalent to the reference listed drug, Percocet Tablets, 5 mg/325 mg and 10 mg/325 mg, of Vintage Pharmaceuticals, LLC.
5 mg and 1 mg, a generic version of the reference listed drug, Teva's Azilect Tablets.
has received final approval from the FDA for the generic equivalent to the reference listed drug (RLD), Tambocor Tablets, 50 mg, 100 mg, and 150 mg (flecainide acetate tablets, USP).
Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg, are therapeutically equivalent to the reference listed drug, Ionamin([R]) Capsules, 15 mg and 30 mg, of UCB, Inc.
5 mg, 5 mg and 10 mg is the therapeutic equivalent to the reference listed drug Focalin Tablets, 2.
ACETO Corporation, an international company engaged in the development, marketing, sale and distribution of Human Health products, Pharmaceutical Ingredients and Performance Chemicals, announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched Atomoxetine Capsules, 10, 18, 25, 40, 60, 80 and 100 mg, an AB rated, generic version of the reference listed drug, Strattera Capsules from Eli Lilly and Co.