2013 FDA Orange Book - New!

Updated Aug 18, 2016:
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.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

It's Here! 2012 FDA Orange Book!

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 - - -

It finally arrived!

The FDA Orange Book for 2012 (32nd Edition)  has just been posted. It's current through Dec 31, 2011.

It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 


Related articles

• Electronic Orange Book Online - It'll be a wait for the 2012 version (drughealth.blogspot.com)

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!

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Orange Book - New - Updated For 2011

Updated Aug 18, 2016:
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!

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

FDA Orange Book 2011 - It Just Arrived!

Updated April 16, 2019:
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!

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Electronic Orange Book Online

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 - - -

The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

FDA Orange Book - Most Current Versions

• People speak highly of this FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc.

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.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

New - FDA Orange Book

• Trusted FDA GMP online training programs and courses by SkillsPlus Intl Inc.

Updated May 26, 2022

The original link broke. You might also be interested in:

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - a webpage

---  the original post follows below  ---

It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Brand New! FDA 2013 Orange Book 33rd Edition (pdf)

Updated March 3, 2020:

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).

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

Return Home: http://drughealth.blogspot.com/ G

FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -
Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

Related Posts:
2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

Return Home: http://drughealth.blogspot.com/

FDA Makes Zometa Inj Orange Book Decision

• GMP Online Training. FDA cGMP QSR GMP online training classes offered by SkillsPlus International Inc.

Updated Dec 17, 2020
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 Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Orange Book Online - Brand New Edition

• FDA GMP QSR cGMP Training - popular online training classes

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

- - - original post below - - -

You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.

According to the FDA, "This publication, 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). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) 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. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."

Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

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)

Return Home: http://drughealth.blogspot.com/

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?

Related Posts:
FDA Orange Book - Online

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Orange Book - Online

• cGMP FDA GMP Training Courses by SkillsPlus International Inc.

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 . . .

1. 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.
2. Orange Book Annual Edition (28th Edition) - The publication identifies drug products approved on the basis of safety and effectiveness.
3. 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.
4. Orange Book - Information and Data Files - Text files for importing into databases.
5. Orange Book Monthly Additions and Deletions - Changes to the annual edition are listed separately by month.
6. Frequently Asked Orange Book Questions
7. Frequently Asked Patent and Exclusivity Questions

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store