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# 2 Stakeholders’ Responses on Orange Book Q&A
- URL: https://www.fdaweb.com/2-stakeholders-responses-on-orange-book-q-a/
- Published: 2020-09-01T12:00:00.000Z
- Updated: 2026-09-14T16:27:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147557

Novo Nordisk responds to an FDA draft guidance, *Orange Book Questions and Answers*, with the observation that the agency does not address the status of authorized generic applications in its answer to a question about which applications are not listed in the *Orange Book*. The company [says](https://downloads.regulations.gov/FDA-2020-D-1068-0004/attachment%5F1.pdf?ref=fdaweb.com) that those not familiar with the book or FDA processes may not understand that an authorized generic is a product that is therapeutically equivalent to the branded drug because it is the same product as the branded drug and that FDA keeps an updated list of authorized generics on its Web site. It recommends that the agency include this information in its answer to this question.

In its [response](https://downloads.regulations.gov/FDA-2020-D-1068-0003/attachment%5F1.pdf?ref=fdaweb.com), Zhejiang Hisun Pharmaceutical Co. submits several pages of line-by-line answers.