Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see FDA Online Label Repository or DailyMed for these Medication Guides). More Drug Name | Active Ingredient | Form;Route | Appl. No. | Company | Date | Xyrem | Sodium Oxybate | SOLUTION;ORAL | 021196 | JAZZ PHARMS | 08/12/2021 | Cellcept | Mycophenolate Mofetil | CAPSULE;ORAL | 050722 | ROCHE PALO | 08/11/2021 | Cellcept | Mycophenolate Mofetil | TABLET;ORAL | 050723 | ROCHE PALO | 08/11/2021 | Cellcept | Mycophenolate Mofetil Hydrochloride | INJECTABLE;INJECTION | 050758 | ROCHE PALO | 08/11/2021 | Cellcept | Mycophenolate Mofetil | SUSPENSION;ORAL | 050759 | ROCHE PALO | 08/11/2021 | Myfortic | Mycophenolic Acid | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 08/11/2021 | Brilinta | Ticagrelor | TABLET;ORAL | 022433 | ASTRAZENECA | 08/10/2021 | Keytruda | Pembrolizumab | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 125514 | MERCK SHARP DOHME | 08/10/2021 | Keytruda | Pembrolizumab | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 125514 | MERCK SHARP DOHME | 08/10/2021 | Lacosamide | Lacosamide | TABLET;ORAL | 204857 | AMNEAL PHARMS NY | 08/10/2021 |
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