CDER Drug Safety Labeling Changes - 7/1/2022

Drug Safety-related Labeling Changes (SrLC) The SrLC database has been updated with the following approved drug safety labeling changes. Drug Name Active Ingredient Application Number Application Type Supplement Date Database Updated PREVACID 24 HR LANSOPRAZOLE 022327 NDA 06/23/2022 07/01/2022 HUMULIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 019717 BLA 06/27/2022 06/30/2022 HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 019717 BLA 06/27/2022 06/30/2022 HUMULIN N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 018781 BLA 06/27/2022 06/30/2022 HUMULIN R INSULIN HUMAN 018780 BLA 06/27/2022 06/30/2022 HUMULIN R KWIKPEN INSULIN HUMAN 018780 BLA 06/27/2022 06/30/2022 HUMULIN R PEN INSULIN RECOMBINANT HUMAN 018780 BLA 06/27/2022 06/30/2022 NITROMIST NITROGLYCERIN 021780 NDA 06/24/2022 06/30/2022 Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA