FDA Submissions for CALAN Verapamil Tablets (NDA 018817)

The FDA’s NDA 018817 pertains to the oral tablet brand CALAN, containing verapamil hydrochloride as the active ingredient. Four product variants are recorded: 40 mg (product 003), 80 mg (product 001), 120 mg (product 002), and 160 mg (product 004). All four tablets are listed with a marketing status of "Discontinued" and each includes a Federal Register note indicating the discontinuation was not for safety or effectiveness reasons. The submission history for this NDA includes several labeling and manufacturing (CMC) filings. Early manufacturing submissions were filed on 29 April 1987 (submission 8) and 4 June 1985 (submission 1). Labeling submissions were filed on 23 August 1988 (submission 11) and 14 February 1990 (submission 13). Additional manufacturing submissions were recorded on 14 May 1996 (submission 18). The most recent activity is a labeling submission (submission 32) approved on 24 August 2016, accompanied by an FDA letter (PDF) dated the same day. These records reflect the regulatory timeline for CALAN verapamil tablets, showing that while the products have been discontinued, the FDA continued to process labeling and manufacturing submissions up to 2016.