INDIANA – 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 |
|---|---|---|---|---|---|
| ACIPHEX | RABEPRAZOLE SODIUM | 020973 | NDA | 07/18/2023 | 07/20/2023 |
| NEXIUM IV | ESOMEPRAZOLE SODIUM | 021689 | NDA | 07/18/2023 | 07/20/2023 |
| PRILOSEC | OMEPRAZOLE MAGNESIUM | 022056 | NDA | 07/18/2023 | 07/20/2023 |
| PROTONIX | PANTOPRAZOLE SODIUM | 020987 | NDA | 07/18/2023 | 07/20/2023 |
| PROTONIX | PANTOPRAZOLE SODIUM | 022020 | NDA | 07/18/2023 | 07/20/2023 |
| PROTONIX IV | PANTOPRAZOLE SODIUM | 020988 | NDA | 07/18/2023 | 07/20/2023 |
| TEPEZZA | TEPROTUMUMAB-TRBW | 761143 | BLA | 07/17/2023 | 07/19/2023 |
| VEKLURY | REMDESIVIR | 214787 | NDA | 07/13/2023 | 07/18/2023 |
| ZYVOX | LINEZOLID | 021130 | NDA | 07/18/2023 | 07/20/2023 |
| ZYVOX | LINEZOLID | 021131 | NDA | 07/18/2023 | 07/20/2023 |
| ZYVOX | LINEZOLID | 021132 | NDA | 07/18/2023 | 07/20/2023 |
