FDA Approves Multiple Submissions for Discontinued Hydrocodone/Acetaminophen Tablet

The FDA’s ANDA database lists a discontinued oral tablet product named HYDROCODONE BITARTRATE AND ACETAMINOPHEN (product number 001). The tablet contains 500 mg acetaminophen and 7.5 mg hydrocodone bitartrate and is administered orally. The product’s marketing status is recorded as Discontinued and it is not identified as a reference drug. A series of supplemental and original submissions for this product have been approved (status “AP”) between 1991 and 2008. Notable entries include: - ORIG #1 approved on 1991‑08‑30. - SUPPL #4 (labeling) approved on 1995‑12‑22. - SUPPL #6 (manufacturing/CMC) approved on 1996‑09‑03. - SUPPL #8 (labeling) approved on 1997‑08‑08. - SUPPL #9 (manufacturing/CMC) approved on 1997‑12‑04. - SUPPL #11 (manufacturing/CMC) approved on 1998‑10‑07. - SUPPL #13 (labeling) approved on 2000‑03‑29. - SUPPL #15 (manufacturing/CMC) approved on 2002‑05‑21. - SUPPL #16 (manufacturing/CMC) approved on 2002‑08‑08. - SUPPL #18 (manufacturing/CMC) approved on 2002‑08‑08. - SUPPL #31 (manufacturing/CMC) approved on 2008‑01‑09. The FDA entry does not provide further information on the reasons for discontinuation or current market availability.