Label Changes for:
Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets
September 2012
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2012
Added:
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules
October 2012
September 2012
- Aciphex (rabeprazole sodium) Delayed-Release Tablets
- Dexilant (dexlansoprazole) Delayed-Release Capsules
- Prevacid (lansoprazole) Delayed-Release Capsules, and Delayed-Release Orally Disintegrating Tablets
- Prilosec (omeprazole) Delayed-Release Capsules, Delayed-Release Oral Suspension
-
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
