FDA Webview
X

Free FDA Notices

Sular Not Withdrawn for S&E

08/25/2014

Federal Register Notice: FDA has determined that Sular (nisoldipine) extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met. To view this notice, click here.

LATEST NEWS