Application 017067
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | BLA | Current |
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-030 | Chorionic Gonadotropin | Chorionic Gonadotropin | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75665 | SUPPL | 2023-10-03 |
| 62217 | APPL | 2020-03-23 |
| 33222 | SUPPL | 2020-03-23 |
| 13079 | SUPPL | 2020-03-23 |