Skip to contentApplication 204958
- Type
- NDA
- Sponsor
- CHIESI
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KENGREAL | CANGRELOR | POWDER;INTRAVENOUS | 50MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10122-620 | KENGREAL | cangrelor | Chiesi USA, Inc. | NDA | Current |
| 10122-620 | KENGREAL | cangrelor | Chiesi USA, Inc. | NDA | Current |
| 10122-620 | KENGREAL | cangrelor | Chiesi USA, Inc. | NDA | Current |
| 10122-620 | KENGREAL | cangrelor | Chiesi USA, Inc. | NDA | Current |
| 65293-003 | KENGREAL | cangrelor | The Medicines Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73345 | SUPPL | 2023-01-31 |
| 73303 | SUPPL | 2023-01-27 |
| 60663 | SUPPL | 2019-10-24 |
| 60650 | SUPPL | 2019-10-24 |
| 24485 | ORIG | 2015-07-29 |
| 22970 | ORIG | 2015-07-29 |
| 60122 | SUPPL | 2015-06-22 |
| 40428 | ORIG | 2015-06-22 |
| 10410 | ORIG | 2015-06-22 |