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 | Droxia | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 08/05/2021 | Hydrea | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 08/05/2021 | Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 08/05/2021 | Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 08/05/2021 | Thalomid | Thalidomide | CAPSULE;ORAL | 020785 | CELGENE | 08/05/2021 | Corlanor | Ivabradine Hydrochloride | TABLET;ORAL | 206143 | AMGEN INC | 08/04/2021 | Corlanor | Ivabradine | SOLUTION;ORAL | 209964 | AMGEN INC | 08/04/2021 | Keytruda | Pembrolizumab | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 125514 | MERCK SHARP DOHME | 08/03/2021 | Arthrotec | Diclofenac Sodium; Misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607 | PFIZER | 08/02/2021 | Oriahnn (Copackaged) | Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | CAPSULE;ORAL | 213388 | ABBVIE INC | 08/02/2021 |
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