Orange Book Medical Devices

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Orange Book: Approved Drug Products with Therapeutic …

https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Additional information and resources for the Orange Book We've updated our mobile app! Download Orange...

Electronic Orange Book | FDA

https://www.fda.gov/drugs/fda-drug-info-rounds-video/electronic-orange-book

The Orange Book has long been a reliable resource for information about FDA-approved drugs. The electronic availability of the Orange Book brings this valuable tool to the web …

Approved Drug Products with Therapeutic Equivalence …

https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved …

Orange Book Preface | FDA - U.S. Food and Drug …

https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface

Jan 24, 2023

Frequently Asked Questions on The Orange Book | FDA

https://www.fda.gov/drugs/drug-approvals-and-databases/frequently-asked-questions-orange-book

First, if you have the trade name, search the Electronic Orange Book's Rx or OTC section using the Proprietary Name search. This determines the ingredient (s). Then use the …

Orange Book Data Files | FDA

https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

In the electronic Orange Book, a reference standard is identified by “RS” in the RS column. Type The group or category of approved drugs. Format is RX, OTC, …

From Our Perspective: The Orange Book at 40: A valued …

https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-orange-book-40-valued-fda-resource-continually-enhanced-user-input

The Orange Book provides information regarding whether each approved drug is a new drug application (NDA) or abbreviated new drug application (ANDA), and, …

Orange Book Questions and Answers Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and-answers-guidance-industry

Center for Drug Evaluation and Research This guidance is intended to assist interested parties (including prospective drug product applicants, drug product …

Should Drug-Delivery Device Patents Be Listed in the …

https://www.finnegan.com/en/insights/articles/should-drug-delivery-device-patents-be-listed-in-the-orange-book.html

For instance, FDA has identified types of patents for “drug products” directed to the drug formulation and delivery device that it believes should be listed in the Orange Book: …

FDA Takes Actions to Enhance Utility of the Orange Book

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-takes-actions-enhance-utility-orange-book

“First published as an official list in 1980, one of the fundamental tools for providing information about generic drugs to the public is the FDA publication Approved …

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