FDA Records Submissions for Teva’s Discontinued Amlodipine/Valsartan/HCTZ Tablets (ANDA 200435)

The FDA database lists five oral tablet products under the brand name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. Each product varies by strength of amlodipine besylate (5 mg or 10 mg equivalent), valsartan (160 mg or 320 mg) and hydrochlorothiazide (12.5 mg or 25 mg). All five entries have a marketing status of “Discontinued.” Several submissions are associated with ANDA 200435. Standard priority labeling submissions (numbers 1, 3 and 4) received an “AP” (approved) status on 2 January 2015 (submissions 1 and 3) and 11 December 2015 (submission 4). An original submission includes a letter dated 27 September 2012 (document 9825). The sponsor for these filings is Teva. Although the products are listed as discontinued, the FDA has processed and approved labeling updates and recorded the original application correspondence, reflecting ongoing regulatory activity for this combination tablet.