FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule

The U.S. Food and Drug Administration has approved Abbreviated New Drug Application (ANDA) number ANDA081069 for an oral capsule product that combines hydrocodeine bitartrate and acetaminophen. The product, marketed under the brand name Hydrocodeine Bitartrate and Acetaminophen, is an oral capsule (product number 001) containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen. The sponsor is Mikart, and the FDA’s record lists the marketing status as discontinued. Submission history for ANDA081069 includes multiple manufacturing (CMC) approvals: submission numbers 1, 2, 3, 4, 5, and 6 were approved on 08 Nov 1995, 08 Feb 1995, 27 Mar 1995, 11 Aug 1995, 31 Jul 1998, and 13 Feb 2002 respectively. A labeling approval (submission number 1) was granted on 13 Jun 1996, and the original submission (submission type ORIG, number 1) received approval on 30 Nov 1989.