Regulatory UpdatesSep 9, 2026•1 min read

FDA Approves ANDA089479 for Acetaminophen/Codeine Phosphate Tablet (Discontinued)

By the PharmaCountry team

The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.

The U.S. Food and Drug Administration has approved application ANDA089479 for an oral tablet formulation containing 300 mg acetaminophen and 30 mg codeine phosphate. The product, marketed under the brand name Acetaminophen and Codeine Phosphate, is listed as discontinued and was submitted by AM THERAP. The original submission (submission 1) received approval on March 3, 1987, and a supplemental labeling amendment (submission 2) was approved on July 14, 1988. No reference drug or reference standard was cited for this ANDA, and the tablet is intended for oral administration.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #acetaminophen #codeine #Oral Tablet