Others titles

  • Exclusivity of Newly Approved Drug
  • Exclusivity of Approved Drug Product
  • Exclusivity of Drugs with Therapeutic Equivalence
  • Drug Book Products with Therapeutic Equivalence Evaluations Exclusivity
  • Drug Products with Therapeutic Equivalence Evaluations Exclusivity Orange Book
  • Generic Drug Products with Therapeutic Equivalence

Keywords

  • Approved Drug
  • Therapeutic Equivalence
  • Drug Exclusivity
  • Drug Book
  • Orange Book
  • Generic Drug Products
  • Drugs List
  • FDA Approved Drug Products

Approved Drug Products with Therapeutic Equivalence Exclusivity

This dataset is also called Orange Book. The dataset contains application type, exclusivity code, exclusivity date etc for approved drug products with therapeutic equivalence.

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Description

The 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).
The Approved Drug Products list first appeared as a print publication in October 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.
The Orange Book Search was added to the FDA website October 31, 1997.

About this Dataset

Data Info

Date Created

1981

Last Modified

2020-10-09

Version

2020-10

Update Frequency

Monthly

Temporal Coverage

1981 to 2020-10

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Approved Drug, Therapeutic Equivalence, Drug Exclusivity, Drug Book, Orange Book, Generic Drug Products, Drugs List, FDA Approved Drug Products

Other Titles

Exclusivity of Newly Approved Drug, Exclusivity of Approved Drug Product, Exclusivity of Drugs with Therapeutic Equivalence, Drug Book Products with Therapeutic Equivalence Evaluations Exclusivity, Drug Products with Therapeutic Equivalence Evaluations Exclusivity Orange Book, Generic Drug Products with Therapeutic Equivalence

Data Fields

Name Description Type Constraints
Application_TypeThe type of new drug application approval. New Drug Applications (NDA or innovator) or Abbreviated New Drug Applications (ANDA or generic).stringrequired : 1
Application_Noo New Drug Application (NDA) Number. The FDA assigned number to the application.integerlevel : Nominalrequired : 1
Product_NoThe FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products.integerlevel : Nominalrequired : 1
Exclusivity_CodeCode to designate exclusivity granted by the FDA to a drug product.stringrequired : 1
Exclusivity_DateThe date the exclusivity expires. Format is YYYY-MM-DD.daterequired : 1

Data Preview

Application TypeApplication NoProduct NoExclusivity CodeExclusivity Date
New Drug Applications (NDA or innovator)91901ODE-642021-04-04
New Drug Applications (NDA or innovator)113662ODE-962022-08-07
New Drug Applications (NDA or innovator)2028711NPP2022-05-16
New Drug Applications (NDA or innovator)2028710NPP2022-05-16
New Drug Applications (NDA or innovator)202879NPP2022-05-16
New Drug Applications (NDA or innovator)202878NPP2022-05-16
New Drug Applications (NDA or innovator)202877NPP2022-05-16
New Drug Applications (NDA or innovator)202876NPP2022-05-16
New Drug Applications (NDA or innovator)202875NPP2022-05-16
New Drug Applications (NDA or innovator)202874NPP2022-05-16