The FDA record for ANDA070493 lists a single oral tablet product named IBUPROFEN (product number 001). The tablet is a 200 mg dosage form, not designated as a reference drug, and its marketing status is listed as Discontinued.
The submission history includes numerous supplemental applications (SUPPL) that received approval (status "AP"). These cover manufacturing (CMC) submissions dated from 1986 to 1998 (e.g., submission numbers 2, 6, 8, 10, 11, 13, 14, 18, 20, 21, 24, 26, 28) and labeling submissions (e.g., numbers 18, 20, 24). Each entry records the submission number, class code, and approval date, indicating ongoing regulatory activity for this product despite its discontinued marketing status.
Regulatorische Updates17. Sept. 2026•3 Min. Lesezeit
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Ibuprofen Tablet
The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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