Application 020898
- Type
- BLA
- Sponsor
- GENZYME
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THYROGEN | THYROTROPIN ALFA | INJECTABLE;INJECTION | 1.1MG/VIAL | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58468-0030 | Thyrogen | THYROTROPIN ALFA | Genzyme Corporation | BLA | Current |
| 58468-0030 | Thyrogen | THYROTROPIN ALFA | Genzyme Corporation | BLA | Current |
| 58468-0030 | Thyrogen | THYROTROPIN ALFA | Genzyme Corporation | NDA | Current |
| 58468-1849 | Thyrogen | THYROTROPIN ALFA | Genzyme Corporation | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 66725 | ORIG | 2021-03-10 |
| 62141 | SUPPL | 2020-03-23 |
| 62140 | SUPPL | 2020-03-23 |
| 62139 | SUPPL | 2020-03-23 |
| 62138 | SUPPL | 2020-03-23 |
| 48147 | SUPPL | 2020-03-23 |
| 48096 | SUPPL | 2020-03-23 |
| 41791 | ORIG | 2020-03-23 |
| 35598 | SUPPL | 2020-03-23 |
| 35597 | SUPPL | 2020-03-23 |
| 35596 | ORIG | 2020-03-23 |
| 26143 | SUPPL | 2020-03-23 |
| 26142 | SUPPL | 2020-03-23 |
| 26141 | SUPPL | 2020-03-23 |
| 13697 | SUPPL | 2020-03-23 |
| 13696 | SUPPL | 2020-03-23 |
| 13695 | SUPPL | 2020-03-23 |
| 13694 | SUPPL | 2020-03-23 |
| 3688 | SUPPL | 2020-03-23 |
| 3687 | SUPPL | 2020-03-23 |
| 3686 | SUPPL | 2020-03-23 |
| 3685 | ORIG | 2020-03-23 |
| 66429 | APPL | 2020-03-22 |