The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.
The FDA assigned number to the application. Format is nnnnnn.
The FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Patent 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.
The date the patent expires as submitted by the applicant holder including applicable extensions. The format is MMM DD, YYYY.
Patents 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.
Patents 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.
Code 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.
Sponsor 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.
The date on which the FDA receives patent information from the new drug application (NDA) holder. Format is Mmm d, yyyy