KOSELUGO
- Product NDC
- 0310-0610
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SELUMETINIB
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA213756
- Marketing category
- NDA
- Substance
- SELUMETINIB
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 0310-0610-28 | 28 CAPSULE in 1 BOTTLE (0310-0610-28) | 20210611 | | No | Historical |
| 0310-0610-60 | 60 CAPSULE in 1 BOTTLE (0310-0610-60) | 20200416 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 7d042c61-f28f-4ab5-ab10-d7558c0d49ff | These highlights do not include all the information needed to use KOSELUGO safely and effectively. See full prescribing information for KOSELUGO. KOSELUGO ® (selumetinib) capsules, for oral use KOSELUGO ® (selumetinib) oral granules Initial U.S. Approval: 2020 | AstraZeneca Pharmaceuticals LP | 2025-11-19 | HUMAN PRESCRIPTION DRUG LABEL | 16 |
| 7d042c61-f28f-4ab5-ab10-d7558c0d49ff | These highlights do not include all the information needed to use KOSELUGO safely and effectively. See full prescribing information for KOSELUGO. KOSELUGO ® (selumetinib) capsules, for oral use KOSELUGO ® (selumetinib) oral granules Initial U.S. Approval: 2020 | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | 2025-09-10 | HUMAN PRESCRIPTION DRUG LABEL | 11 |