Regulatory UpdatesSep 25, 2026•1 min read

FDA Approves ANDA090468 for ZYFREL Oral Solution (Acetaminophen/Hydrocodone)

By the PharmaCountry team

Cypress Pharm Inc.'s ZYFREL oral solution (acetaminophen 325 mg/15 mL and hydrocodone 7.5 mg/15 mL) received FDA approval under ANDA090468, with labeling supplements approved in 2016 and 2017.

The U.S. Food and Drug Administration has approved application ANDA090468 submitted by Cypress Pharm Inc. for the oral solution product ZYFREL. The solution contains acetaminophen 325 mg per 15 mL and hydrocodone bitartrate 7.5 mg per 15 mL. The original submission (submission number 1) was approved on April 14, 2016, as documented in the FDA approval letter dated April 19, 2016. Subsequent supplemental submissions focused on labeling were also approved: submission number 2 on December 16, 2016 and submission number 3 on November 28, 2017. ZYFREL is listed as a discontinued product in the FDA database. The product is administered orally in a solution dosage form. No reference drug or reference standard was cited for this ANDA. For full details, refer to the FDA approval letter and related submission documents.

Compiled by the PharmaCountry team · Source: FDA.gov