Application 761033
- Type
- BLA
- Sponsor
- TEVA RESPIRATORY LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CINQAIR | RESLIZUMAB | INJECTABLE;INJECTION | 100MG/10ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59310-610 | CINQAIR | Reslizumab | Teva Respiratory, LLC | BLA | Current |
| 59310-610 | CINQAIR | Reslizumab | Teva Respiratory, LLC | BLA | Current |
| 59310-610 | CINQAIR | Reslizumab | Teva Respiratory, LLC | BLA | Current |
| 59310-610 | CINQAIR | Reslizumab | Teva Respiratory, LLC | BLA | Current |
| 59310-610 | CINQAIR | Reslizumab | Teva Respiratory, LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57253 | SUPPL | 2019-01-18 |
| 57172 | SUPPL | 2019-01-10 |
| 44978 | ORIG | 2016-05-05 |
| 23056 | ORIG | 2016-05-05 |
| 20001 | ORIG | 2016-03-29 |
| 10661 | ORIG | 2016-03-29 |
| 51639 | ORIG | 1900-01-01 |
| 51638 | ORIG | 1900-01-01 |
| 51637 | ORIG | 1900-01-01 |