Drug Safety Labeling Changes (SLC)
The SLC database has been updated with the following approved drug safety labeling changes.| Drug Name | Active Ingredient | Application Number | Application Type | Supplement Date | Database Updated |
|---|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | 022434 | NDA | 06/18/2018 | 06/26/2018 |
| AZACTAM | AZTREONAM | 050580 | NDA | 06/18/2018 | 06/26/2018 |
| AZACTAM IN PLASTIC CONTAINER | AZTREONAM | 050632 | NDA | 06/18/2018 | 06/26/2018 |
| BONJESTA | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 209661 | NDA | 06/18/2018 | 06/26/2018 |
| DARZALEX | DARATUMUMAB | 761036 | BLA | 06/18/2018 | 06/26/2018 |
| DICLEGIS | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 021876 | NDA | 06/18/2018 | 06/26/2018 |
| KEYTRUDA | PEMBROLIZUMAB | 125514 | BLA | 06/19/2018 | 06/26/2018 |
| NEULASTA | PEGFILGRASTIM | 125031 | BLA | 06/18/2018 | 06/26/2018 |
| PEPCID | FAMOTIDINE | 019462 | NDA | 06/21/2018 | 06/26/2018 |
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