FDA Approves Multiple Submissions for APRESAZIDE (ANDA 084735)

The FDA’s ANDA 084735 concerns the oral capsule product APRESAZIDE, which contains 25 mg of hydralazine hydrochloride and 25 mg of hydrochlorothiazide per capsule. The product’s marketing status is recorded as discontinued. The application includes an original approval (submission 1) dated 26 May 1976 and a succession of supplemental submissions that have been approved (status AP). These supplements cover manufacturing (CMC) updates—e.g., submissions 14 (16 Sep 1983), 20 (22 Aug 1988), 24 (9 Feb 1989), 30 (18 Jun 1992), 22 (30 Apr 1992), 36 (20 Nov 1998)—as well as labeling changes—e.g., submissions 26 (3 Aug 1988), 34 (30 Jan 1996), 32 (4 Nov 1992). All listed submissions have an approved status, reflecting ongoing regulatory activity for the product before its discontinuation.