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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 |
| Tyenne |
Tocilizumab-Aazg |
INJECTABLE;SUBCUTANEOUS |
761449 |
FRESENIUS KABI USA, LLC |
05/20/2026 |
| Tyenne |
Tocilizumab--Aazg |
INJECTABLE;SUBCUTANEOUS |
761275 |
FRESENIUS KABI USA LLC |
05/20/2026 |
| Venclexta |
Venetoclax |
TABLET;ORAL |
208573 |
ABBVIE INC |
05/20/2026 |
| Immgolis and Immgolis Intri |
Golimumab |
INJECTION, SOLUTION |
761452 |
ACCORD BIOPHARMA INC. |
05/19/2026 |
| Ocrevus |
Ocrelizumab |
INJECTABLE;INJECTION |
761053 |
GENENTECH INC |
05/19/2026 |
| Wezlana |
Ustekinumab-Auub |
INJECTABLE;SUBCUTANEOUS, INTRAVENOUS |
761331 |
AMGEN INC |
05/19/2026 |
| Wezlana |
Ustekinumab-Auub |
INJECTABLE;SUBCUTANEOUS, INTRAVENOUS |
761285 |
AMGEN INC |
05/19/2026 |
| Enhertu |
Fam-Trastuzumab Deruxtecan-Nxki |
INJECTABLE;INJECTION |
761139 |
DAIICHI SANKYO |
05/18/2026 |
| Mavenclad |
Cladribine |
TABLET;ORAL |
022561 |
EMD SERONO INC |
05/18/2026 |
| Tecentriq |
Atezolizumab |
INJECTABLE;INJECTION |
761034 |
GENENTECH INC |
05/18/2026 |
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