> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# B. Braun Wants AP Ratings for Some Drugs
- URL: https://www.fdaweb.com/b-braun-wants-ap-ratings-for-some-drugs/
- Published: 2020-03-12T12:00:00.000Z
- Updated: 2026-09-14T16:06:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146313

B. Braun Medical is petitioning FDA to assign AP therapeutic equivalence (TE) ratings to the listings for specified company products in the *Orange Book*. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-1065-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the drug products currently have no TE rating assigned. All of the products for which the company seeks an AP rating are considered 505(b)(2) products, the petition says. At the time of their original submissions, they relied upon literature or reference-listed drugs to support their approval, the company says. None of the products were submitted as new molecular entities.

“The products listed in Appendix 1 are all powder for solution (or solution) injectable products for which there are no known or suspected bioequivalence problems,” the petition says. “Therefore, we believe ‘AP’ TE codes should be added to the *Orange Book*.”