FDA’s ANDA 071144 pertains to an oral ibuprofen tablet (product number 001) marketed as a 200 mg tablet. The product is listed with a discontinued marketing status and is not a reference listed drug.
The submission history includes an original filing (ORIG) on 20 January 1987, followed by multiple supplemental (SUPPL) filings. Manufacturing (CMC) supplements were approved on 30 June 1988 (submission numbers 7, 8, 9), 6 April 1988 (submission 6), 8 July 1988 (submission 5), 11 January 1989 (submission 11), 7 December 1990 (submission 12), 8 January 1990 (submission 14), 16 December 1992 (submission 3), and 5 May 1997 (submission 20). Labeling supplements were approved on 8 July 1988 (submission 4), 25 April 1989 (submission 13), and 16 December 1992 (submission 1). The latest listed approval date is 5 May 1997.
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FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.
Tổng hợp bởi đội ngũ Pharmacountry · Nguồn: FDA.gov
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