Application 017067
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 017067 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | Disc | 2026-06-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 5,000 UNITS/VIAL | No | No |
| 002 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 10,000 UNITS/VIAL | No | No |
| 003 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 20,000 UNITS/VIAL | No | No |
| 004 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 15,000 UNITS/VIAL | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chorionic Gonadotropin | CHORIONIC GONADOTROPIN | Fresenius Kabi USA, LLC | f93b2baa-03ac-4650-b35a-20b818d712d6 | 2025-04-11 | Warnings, Adverse reactions | BLA017067 63323-030 |
| Chorionic Gonadotropin | CHORIONIC GONADOTROPIN | NuCare Pharmaceuticals,Inc. | 312ee87a-c6c3-6111-e063-6394a90ad8d7 | 2025-03-25 | Warnings, Adverse reactions | BLA017067 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | BLA | Current |