Application 017016
- Type
- BLA
- Sponsor
- FERRING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 004 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 20,000 UNITS/VIAL | No | No |
| 006 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 5,000 UNITS/VIAL | No | No |
| 007 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 10,000 UNITS/VIAL | No | No |
| 009 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 2,000 UNITS/VIAL | No | No |
| 010 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 15,000 UNITS/VIAL | No | No |
| 011 | CHORIONIC GONADOTROPIN | GONADOTROPIN, CHORIONIC | INJECTABLE;INJECTION | 2,000 UNITS/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55566-1501 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1501 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1501 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1501 | Novarel | Gonadotrophin, Chorionic | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1501 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1502 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1502 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1502 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | BLA | Current |
| 55566-1502 | Novarel | Gonadotrophin, Chorionic | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-1502 | Novarel | gonadotrophin, chorionic | Ferring Pharmaceuticals Inc. | NDA | Current |