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Application 214998
- Type
- NDA
- Sponsor
- MYOKARDIA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAMZYOS | MAVACAMTEN | CAPSULE; ORAL | 2.5MG | No | No |
| 002 | CAMZYOS | MAVACAMTEN | CAPSULE; ORAL | 5MG | No | No |
| 003 | CAMZYOS | MAVACAMTEN | CAPSULE; ORAL | 10MG | No | No |
| 004 | CAMZYOS | MAVACAMTEN | CAPSULE; ORAL | 15MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73625-111 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-111 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-111 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-111 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-112 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-112 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-112 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-112 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-113 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-113 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-113 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-113 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-114 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-114 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-114 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |
| 73625-114 | CAMZYOS | mavacamten | Myokardia, Inc. | NDA | Current |