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Application 103532
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PULMOZYME | DORNASE ALFA | VIAL | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
| 50242-100 | Pulmozyme | dornase alfa | Genentech, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85124 | SUPPL | 2026-02-24 |
| 77474 | SUPPL | 2024-02-12 |
| 77466 | SUPPL | 2024-02-12 |
| 68272 | SUPPL | 2021-08-03 |
| 68241 | SUPPL | 2021-08-02 |
| 18587 | SUPPL | 2014-12-15 |
| 9395 | SUPPL | 2014-12-15 |