Read the full article: FDA Law Blog: Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut:
"On January 25, 2017, The Orange Book data will be updated to reflect the recent publication of the draft guidance for industry ‘Referencing Approved Drug Products in ANDA Submissions."
'via Blog this'
Go to the FDA webpage:
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
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Showing posts with label orange book. Show all posts
Showing posts with label orange book. Show all posts
Wednesday, January 25, 2017
Tuesday, November 10, 2015
There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
Read the full article: FDA Law Blog: There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App:
" . . allows users to search by Active Ingredient, Proprietary Name, Applicant Holder, Application Number, and Patent Number. Search results are displayed with tabs showing listings in the Prescription Drug Product List, the Over-the-Counter Drug Product List, and the Discontinued Drug Product List sections of the Orange Book. Each drug product listing links to the same patent and exclusivity information appearing in the paper and electronic versions of the Orange Book, and . . . "
'via Blog this'
You might also be interested in:
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Wednesday, February 27, 2013
2013 FDA Orange Book - New!
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
- - original post follows below - -
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (pdf) has just been posted on the FDA's website.
It's the 33rd edition.
It lists products that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume is current through December 31, 2012.
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Wednesday, November 23, 2011
Electronic Orange Book Online - It'll be a wait for the 2012 version
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
Electronic Orange Book Online | The Health, Drug, Prescription, and GMP Supersite: 'via Blog this'
OK you eager beavers out there! If history serves us, you'll have to wait until the end of Q1 2012 to see a brand new cumulative version of the Orange Book that is current through the end of 2011.
In the meantime, just navigate to the link provided above for your needs.
Happy hunting, and be patient!
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Monday, May 16, 2011
FDA Orange Book - New - Updated For 2011
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.
It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.
If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Happy hunting!
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Thursday, March 3, 2011
FDA Orange Book 2011 - It Just Arrived!
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
I've been watching and waiting for this to be released.
It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.
If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
Happy hunting!
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Monday, September 13, 2010
Electronic Orange Book Online
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.
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Monday, August 9, 2010
FDA Orange Book - Most Current Versions
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that 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.
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FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that 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.
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Monday, February 22, 2010
Brand New! FDA 2013 Orange Book 33rd Edition (pdf)
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
New! - The 2010 FDA Approved Drug Products with Therapeutic Equivalence Evaluations 30th Edition (also known as the Orange Book).
Complete! - This FDA Orange Book 30th Edition is current through December 31, 2009.
Learn more about the Orange Book on the FDA website - Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).
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Monday, February 23, 2009
Easy FDA Orange Book Search Widget
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
You can perform your FDA Orange Book searches on the FDA's site, or you can use this Search Orange Book Widget to conduct your searches using a single interface. No more switching back and forth between multiple web pages! I used the widget as is, at the link location above. Some of you more tech savvy folks might consider installing the widget. Here's what the widget creator says . . .
by viswanathaa
Created 10/28/08
With all search options conveniently under one window, this widget allows one to search the US FDA electronic orange book faster & from your own homepage.
Happy hunting!
Related Posts:
FDA Orange Book - Online
About The FDA Orange Book - Slide Deck (free)
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Tuesday, January 6, 2009
About The FDA Orange Book - Slide Deck (free)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post below - - -
If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .
- What is the Orange Book?
- What is exclusivity and how does it work?
- How is the Food and Drug Administration (FDA) involved with patent protection?
FDA Orange Book - Online
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Thursday, September 4, 2008
FDA Orange Book - Online
FDA Orange Book - Online
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
- - original post follows below - -
In case you didn't know, the FDA's Orange Book is now available online. The folks at Foley & Lardner LLP state, "The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA's website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products." The FDA website makes the following Orange Book resources available to you . . .
- - original post follows below - -
In case you didn't know, the FDA's Orange Book is now available online. The folks at Foley & Lardner LLP state, "The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA's website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products." The FDA website makes the following Orange Book resources available to you . . .
- Orange Book Query - The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number.
- Orange Book Annual Edition (28th Edition) - The publication identifies drug products approved on the basis of safety and effectiveness.
- Orange Book Current Cumulative Supplement - The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.
- Orange Book - Information and Data Files - Text files for importing into databases.
- Orange Book Monthly Additions and Deletions - Changes to the annual edition are listed separately by month.
- Frequently Asked Orange Book Questions
- Frequently Asked Patent and Exclusivity Questions
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