FDA Approves ANDA089479 for Acetaminophen/Codeine Phosphate Tablet (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.