Approved Drug Products with Therapeutic Equivalence Evaluations, 1999Barry Leonard Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products. |
Common terms and phrases
10MG BASE 1GM BASE/VIAL EQ ACETAMINOPHEN ACETATE ALPHARMA AMINO ACIDS AP AP AP APOTHECON ASPIRIN BASE EQ 500MG BASE/ML EQ BASE/VIAL EQ 1GM BAXTER HLTHCARE CALCIUM CHLORIDE CAPSULE CHELSEA LABS CHLORPHENIRAMINE MALEATE CITRATE CODEINE PHOSPHATE DANBURY PHARMA DEXAMETHASONE DEXTROSE DEXTROSE POTASSIUM CHLORIDE DISCONTINUED DRUG PRODUCT DRUG PRODUCT LIST EQ 10MG EQ 1GM BASE/VIAL EQ 250MG BASE EQ 500MG BASE/VIAL ERYTHROMYCIN ETHINYL ESTRADIOL EXTENDED RELEASE GENEVA PHARMS GLAXO WELLCOME HEPARIN SODIUM HYDRALAZINE HYDROCHLORIDE HYDROCHLORIDE TABLET HYDROCHLOROTHIAZIDE HYDROCORTISONE IBUPROFEN LEDERLE LIDOCAINE LISTED BY APPLICANT MESYLATE MYLAN NAME INDEX LISTED NOVARTIS NUMBER OPHTHALMIC ORAL P.O. Box patients PHARM PARTNERS Pharmaceuticals PHARMACIA AND UPJOHN POTASSIUM CHLORIDE PRESCRIPTION DRUG PRODUCT PRODUCT NAME INDEX PUREPAC PHARM ROXANE SCHERING SODIUM CHLORIDE SODIUM CHLORIDE 0.9 SODIUM PHOSPHATE STERIS SULFAMETHOXAZOLE TARTRATE TECHNETIUM TECHNETIUM TC-99M TEVA THEOPHYLLINE therapeutic equivalence TOPICAL Treatment UNITS/ML WYETH AYERST ZENITH GOLDLINE
Popular passages
Page xiii - ... that FDA at this time does not consider to be therapeutically equivalent to other pharmaceutically equivalent products, ie, drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence. Often the problem is with specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, or BX.24 FDA has adopted an additional subcategory of B codes.
Page 3-602 - Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in pretero Infants.
Page viii - ... pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration,...
Page 3-549 - For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age.
Page xxiii - If a prescription drug product is available from more than one source (multisource), a therapeutic equivalence code will appear in front of the applicant's name. If a product is therapeutically equivalent to one or more products or to an appropriate reference, it will be designated with a code beginning with "A" and the entry will be underlined and printed in bold font for emphasis.
Page 3-539 - FOR THE ACUTE TREATMENT AND PROPHYLAXIS OF LIFE-THREATENING VENTRICULAR TACHYCARDIA OR VENTRICULAR FIBRILLATION.
Page viii - ... standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; and (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations. The concept of therapeutic equivalence,...
Page viii - ... packaging, excipients (including colors, flavors, preservatives), expiration time and minor aspects of labeling (eg, the presence of specific pharmacokinetic information). When such differences are important in the care of a particular patient, it may be appropriate for the prescribing physician to require that a particular brand be dispensed as a medical necessity. With this limitation, however, FDA believes that products classified as therapeutically equivalent can be substituted with the full...
Page xx - Drug products for which the data are insufficient to determine therapeutic equivalence The code BX is assigned to specific drug products for which the data that have been reviewed by the Agency are insufficient to determine therapeutic equivalence under the policies stated in this document. In these situations, the drug products are presumed to be therapeutically inequivalent until the Agency has determined that there is adequate information to make a full evaluation of therapeutic equivalence.
Page 3-611 - TA 止日丁: ０ 肌l 25０MG ASPIRIN: BUTALBITAL CAPSULE OR TABLET. ORAL 325MG: 50MG 650MG. 50MG HYDROXYZINE HYDROCHLORIDE TABLET: ORAL 10MG: 25MG: 50MG: 100MG ASPIRIN: BUTALBITAL: CAFFEINE CAPSULE OR TABLET: ORAL 325MG: 50MG: 40MG 650MG: 50MG: 40MG PREDNISONE...