FDA Approves Multiple Supplemental Applications for Discontinued Chlorothiazide Tablets (ANDA 084217)

The FDA database entry for ANDA 084217 documents two oral tablet products containing chlorothiazide. Product 001 is a 500 mg tablet and product 002 is a 250 mg tablet; both are listed with a marketing status of "Discontinued" and are not reference drugs. The record also includes a sequence of approved supplemental (SUPPL) submissions. These submissions span manufacturing (CMC), labeling, and bioequivalence categories. Notable entries include: - Submission 177 (Manufacturing CMC) approved on 26 Mar 1982. - Submission 88 (Bioequivalence) approved on 13 Jul 1989. - Submission 187 (Labeling) approved on 06 Dec 1989. - Submission 191 (Labeling) approved on 11 Mar 1994. - Submission 195 (Manufacturing CMC) approved on 25 Jan 2001. - Submission 198 (Labeling) approved on 04 Apr 2005. All listed submissions carry an "AP" status, indicating FDA approval for the respective changes. These data reflect the regulatory history of the discontinued chlorothiazide tablet products and the FDA’s approval of multiple supplemental applications over more than two decades.