Fda Orange Book

. Downloadable Data Files for the Orange BookThe the compressed (ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII text, tilde delimited format. Please note the recent changes to the below. Updated. The Orange Book Appendices are available in PDF format.You can search by active ingredient, proprietary name, applicant, or application number.Additional Information and Resources for the Orange BookData Files and Orange Book Appendices.Orange Book Publications and Help Files.Data Descriptions.

Products.txt. IngredientThe active ingredient(s) for the product. Multiple ingredients are in alphabetical order, separated by a semicolon. Dosage form; Route of AdministrationThe product dosage form and route separated by a semi-colon.

The format is not all uppercase. Trade NameThe trade name of the product as shown on the labeling. ApplicantThe firm name holding legal responsibility for the new drug application. The firm name is condensed to a maximum twenty character unique string. StrengthThe potency of the active ingredient.

May repeat for multiple part products. New Drug Application TypeThe type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”. New Drug Application (NDA) NumberThe FDA assigned number to the application. Format is nnnnnn. Product NumberThe FDA assigned number to identify the application products.

Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) CodeThe TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval DateThe date the product was approved as stated in the FDA approval letter to the applicant.

The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: 'Approved prior to Jan 1, 1982'. Reference Listed Drug (RLD)The RLD is a drug product approved under section 505(c) of the FD&C Act for which FDA has made a finding of safety and effectiveness. In the electronic Orange Book, an RLD is identified by “RLD” in the RLD column. Reference Standard (RS)A “reference standard” is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval of an ANDA.

In the electronic Orange Book, a reference standard is identified by “RS” in the RS column. TypeThe group or category of approved drugs. Format is RX, OTC, DISCN. Applicant Full NameThe full name of the firm holding legal responsibility for the new drug application.

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Patent.txt. New Drug Application TypeThe type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.

New Drug Application (NDA) NumberThe FDA assigned number to the application. Format is nnnnnn.

Product NumberThe FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Patent NumberPatent numbers as submitted by the applicant holder for patents covered by the statutory provisions. May repeat for multiple applications and multiple products. Includes pediatric exclusivity granted by the agency.

Format is nnnnnnnnnnn. Patent Expire DateThe date the patent expires as submitted by the applicant holder including applicable extensions.

The format is MMM DD, YYYY. Drug Substance FlagPatents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance. Format is Y or null.

Drug Product FlagPatents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product. Format is Y or null. Patent Use CodeCode to designate a use patent that covers the approved indication or use of a drug product. May repeat for multiple applications, multiple products and multiple patents. Format is nnnnnnnnnn. Patent Delist Request FlagSponsor has requested patent be delisted.

This patent has remained listed because, under Section 505(j)(5)(D)(i) of the Act, a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification to this patent for a certain period. Applicants under Section 505(b)(2) are not required to certify to patents where this flag is set to Y. Format is Y or null. Patent Submission DateThe date on which the FDA receives patent information from the new drug application (NDA) holder. Format is Mmm d, yyyy. Exclusivity.txt. New Drug Application TypeThe type of new drug application approval.

New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”. New Drug Application (NDA) NumberThe FDA assigned number to the application. Format is nnnnnn. Product NumberThe FDA assigned number to identify the application products.

Each strength is a separate product. May repeat for multiple part products. Format is nnn. Exclusivity CodeCode to designate exclusivity granted by the FDA to a drug product. Format is nnnnnnnnnn. Exclusivity DateThe date the exclusivity expires.

Format is MMM DD, YYYY.Orange Book Publications and Help Files.Annual Edition; Current Cumulative Supplement; Additions/Deletions, Orange Book Help and Background Information, FAQs and the Orange Book Preface.

This article relies largely or entirely on a single. Relevant discussion may be found on the. Please help by introducing to additional sources.Find sources: – ( October 2018)The (Hatch-Waxman Act) requires to publish Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.The Orange Book identifies products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the. The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing DESI review e.g., Tablets and Capsules or pre-1938 drugs e.g., Tablets). 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 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 Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote in the area of drug product selection and to foster containment of costs.

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Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.References.