| 510(k) Number | Decision Date | Decision | Statement or Summary | Device Name |
|---|---|---|---|---|
"This page contains brief information about idecabtagene vicleucel
and ... | Idecabtagene Vicleucel | |||
| andpossible side effects. Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However | what you should tell your doctor before using this drug | what this drug is used for and how it is used | ||
| Yes | Abemaciclib works by blocking the activity of proteins called CDK4 and CDK6 that... | Abemaciclib | ||
| and ongoing clinical trials." | "This page contains brief information about abiraterone acetate (Yonsa | Abiraterone Acetate | ||
| Abraxane | "Paclitaxel albumin-stablilized nanoparticle formulation is a different form of ... | Paclitaxel Albumin-stabilized Nanoparticle Formulation | ||
| and dacarbazine. Combinations usually work better than single drugs because different drugs kill cancer cells in different ways." | "This chemotherapy combination contains the drugs doxorubicin hydrochloride (Adr... | ABVD | ||
| and etoposide phosphate. Combinations usually work better than single drugs because different drugs kill cancer cells in different ways." | "This chemotherapy combination contains the drugs doxorubicin hydrochloride (Adr... | ABVE | ||
| etoposide phosphate | "This chemotherapy combination contains the drugs doxorubicin hydrochloride (Adr... | ABVE-PC | ||
"This chemotherapy combination contains the drugs doxorubicin hydrochloride (Adr... | AC | |||
"This page contains brief information about acalabrutinib
maleate monoh... | Acalabrutinib Maleate Monohydrate |