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 ?
Diethylproprion HCl Tablets, 25 mg, is therapeutically equivalent to the reference listed drug, Tenuate([R]) Tablets, 25 mg, of Watson Pharmaceuticals.
Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equal to the reference listed drug product (RLD) Diovan?
According to FDA, the ANDA is bioequivalent therefore, therapeutically equivalent to the reference listed drug, Cyklokapron - tranexamic acid injection solution.
This product was entirely self-developed and manufactured by Amerigen and is the first ANDA approved for which Lodosyn is the reference listed drug.
Mylan's product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Naloxone Hydrochloride Injection 0.
s OXECTA (oxycodone HCl) Tablets CII as the reference listed drug.
s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg.
Amlodipine Besylate and Benazepril Hydrochloride capsules are the generic bioequivalent to the reference listed drug LotrelA capsules of Novartis Pharmaceuticals Corp.
While the FDA did not comment upon any particular filing, the agency stated that: "The practical effect of this determination is that any application for a testosterone gel product that has different penetration enhancers than the reference listed drug cannot be submitted as an ANDA [(i.
First generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review.
Taro's carbamazepine extended-release tablets are bioequivalent to the reference listed drug Tegretol[R]-XR Tablets of Novartis Pharmaceuticals Corporation, a prescription pharmaceutical product used for treating seizures.