FDA Approves ACETAZOLAMIDE Oral Tablet (ANDA084840)

The Food and Drug Administration (FDA) has granted approval for an Abbreviated New Drug Application (ANDA) covering ACETAZOLAMIDE oral tablets (250 mg) marketed as a prescription product (product number 001). The tablet is administered orally and contains the active ingredient acetazolamide at a strength of 250 mg. The original ANDA (submission type ORIG, submission number 1) received approval on 31 March 1978. Since then, the FDA has approved a series of supplemental submissions (SUPPL) addressing labeling and manufacturing (CMC) requirements. Notable approvals include: - Labeling supplements: submission numbers 8 (approved 4 August 1988), 11 (5 June 1990), 16 (26 July 1996), 19 (12 December 2001), 23 (29 May 2008). - Manufacturing (CMC) supplements: submission numbers 3 (16 November 1981), 7 (27 June 1994), 14 (26 July 1996), 15 (26 July 1996), 17 (26 July 1996), 18 (10 August 2000), 26 (24 October 2016). All listed supplemental submissions have a status of AP (approved). The product is not designated as a reference drug and does not have a reference standard. These approvals confirm the continued regulatory compliance of the ACETAZOLAMIDE tablet for both its labeling information and manufacturing processes.