Cập nhật pháp chế28 thg 8, 2026•1 phút đọc

FDA Approves Multiple Submissions for LORTAB (ANDA 087722)

Tác giả: đội ngũ PharmaCountry

The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.

LORTAB, an oral tablet containing 500 mg acetaminophen and 5 mg hydrocodone bitartrate, is listed in the FDA database as discontinued. The product was never designated as a reference drug. The FDA’s ANDA 087722 record shows numerous approved submissions. Manufacturing (CMC) submissions were approved on dates including 13 May 1985 (submission 8), 13 Jan 1984 (submission 2), 14 Dec 1988 (submission 23), 14 Dec 1988 (submission 25), 26 Feb 1993 (submission 31), 21 Jan 1994 (submission 34), 29 Oct 1998 (submission 21), and 29 Jun 1999 (submission 38). A labeling submission (submission 36) received approval on 1 Mar 1996. The original ANDA (submission 1) was approved on 9 Jul 1982. These entries reflect the regulatory history of LORTAB under ANDA 087722, documenting the FDA’s approvals for manufacturing and labeling over a 17‑year period before the product’s discontinuation.

Tổng hợp bởi đội ngũ PharmaCountry · Nguồn: FDA.gov