tailieunhanh - APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

Description: Identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. | CUMULATIVE SUPPLEMENT 10 OCTOBER 2012 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 32nd EDITION Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs 2012 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 32nd EDITION Cumulative Supplement 10 October 2012 CONTENTS PAGE How to use the Cumulative Cumulative Supplement Applicant Name Levothyroxine Availability of the Report of Counts for the Prescription Drug Product Cumulative Supplement DRUG PRODUCT LISTS Prescription Drug Product OTC Drug Product Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Orphan Product Designations and Approvals Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Lists . A-1 B. Patent and Exclusivity Terms . .