Approved Drug Products With Therapeutic Equivalence Evaluations 1999

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

FDA Orange Book 32nd Edition - 2012 (Approved Drug Products With Therapeutic Equivalence Evaluations)

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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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.

FDA Orange Book 31st Edition - 2011 (Approved Drug Products With Therapeutic Equivalence Evaluations)

NESINA Drug Profile, 2023

This report focuses on NESINA and covers the following critical aspects of this drug:

• United States patents
• Expired United States patents
• FDA Paragraph IV patent challenges
• District Court patent litigation
• European supplementary protection certificates (SPCs)
• Clinical trials
• Drug prices
• Finished product suppliers
• Raw active pharmaceutical ingredient (API) sources

FDA Orange Book 30th Edition - 2010 (Approved Drug Products With Therapeutic Equivalence Evaluations)