Regulatory UpdatesSep 5, 2026•1 min read

FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet

By the PharmaCountry team

The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.

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.

Compiled by the PharmaCountry team · Source: FDA.gov