Application 020168
- Type
- BLA
- Sponsor
- GENENTECH
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 020168 | Nutropin | somatropin | 351(a) | Disc | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUTROPIN | SOMATROPIN | INJECTABLE;INJECTION | 5MG/VIAL | No | No |
| 002 | NUTROPIN | SOMATROPIN | INJECTABLE;INJECTION | 10MG/VIAL | No | No |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Serostim | SOMATROPIN | EMD Serono, Inc. | 62b01d29-90f0-45b2-a0c4-3a750ba36c8a | 2026-07-28 | Warnings, Adverse reactions | SOMATROPIN |
| GENOTROPIN | SOMATROPIN | Pfizer Laboratories Div Pfizer Inc | ffebf88b-d257-4542-9808-74d9b7167765 | 2026-04-30 | Warnings, Adverse reactions | SOMATROPIN |
| HUMATROPE | SOMATROPIN | Eli Lilly and Company | a774e1ae-3997-49ee-8b0e-99a2b315d409 | 2025-11-25 | Warnings, Adverse reactions | SOMATROPIN |
| ZOMACTON | SOMATROPIN | Ferring Pharmaceuticals Inc. | 85ba081b-bee0-4a9a-aa0f-ae5b5e9a0886 | 2025-11-14 | Warnings, Adverse reactions | SOMATROPIN |
| Omnitrope | SOMATROPIN | Sandoz Inc | 58d84ffa-4056-4e36-ad67-7bd4aef444a5 | 2025-07-10 | Warnings, Adverse reactions | SOMATROPIN |
| Norditropin | SOMATROPIN | Novo Nordisk | 1058e17c-9261-459c-a3e6-fae38d196c14 | 2025-07-07 | Warnings, Adverse reactions | SOMATROPIN |