Generically equivalent drug definition
Generically equivalent drug means a drug that contains identical amounts of the identical active ingredients, but not necessarily containing the same inactive ingredients, that meets the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency, and where applicable, content uniformity, disintegration times, or dissolution rates, as the prescribed brand name drug and the manufacturer or distributor holds, if applicable, either an approved new drug application or an approved abbreviated new drug application unless other approval by law or from the federal food and drug administration is required.
Generically equivalent drug means a drug product that the Commissioner of Food and Drugs of the United States Food and Drug Administration has approved as safe and effective and has determined to be therapeutically equivalent, as listed in “The Approved Drug Products with Therapeutic Equivalence Evaluations” (Food and Drug Administration “Orange Book”), provided, however, that drug products found by the United States Food and Drug Administration to have a narrow therapeutic range shall not be considered generically equivalent for the purposes of this act.
Generically equivalent drug means a therapeutically equivalent generic drug product which may be substituted for a brand name drug under section 20-619(b) of the Connecticut General Statutes;
More Definitions of Generically equivalent drug
Generically equivalent drug means a drug that contains identical active ingredients in the identical dosage forms, but not necessarily containing the same inactive ingredients, that meet the identical compendial or other applicable standards of identity, strength, quality and purity, including potency, and, where applicable, content uniformity, disintegration times or dissolution rates, as the prescribed brand name drug, and, if applicable, the manufacturer or distributor holds either an approved new drug application or an approved abbreviated new drug application unless other approval by law or from the Federal Food and Drug Administration is required. A generically equivalent drug shall bear an "AB" or higher rating in the Federal Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations;
Generically equivalent drug means a drug that is
Generically equivalent drug means a drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name, as determined by the United States Adopted Names Council and accepted by the federal Food and Drug Administration, as those drug products having the same chemical ingredient.
Generically equivalent drug means a drug that contains identical amounts of the identical active ingredients, but not necessarily containing the same inactive ingredients, that meets the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency, and where applicable, content uniformity, disintegration times,
Generically equivalent drug means a drug (1) that contains identical amounts of the identical active ingredients, but not necessarily containing the same inactive ingredients,