FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet

The FDA has approved application ANDA085964 for an oral tablet product named Acetaminophen and Codeine Phosphate. The tablet contains 300 mg of acetaminophen and 60 mg of codeine phosphate per dose. It is marketed by Sandoz and is currently listed with a marketing status of discontinued. Submission history includes an original submission (number 1) approved on 1978‑07‑18, followed by several supplemental labeling submissions (numbers 40, 42, 43, 44, 45) approved between 1988 and 1991. The product is not designated as a reference drug and does not have a reference standard.