Application 022201
- Type
- NDA
- Sponsor
- FERRING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FIRMAGON | DEGARELIX ACETATE | POWDER;SUBCUTANEOUS | EQ 80MG BASE/VIAL | Yes | No |
| 002 | FIRMAGON | DEGARELIX ACETATE | POWDER;SUBCUTANEOUS | EQ 120MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55566-8303 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8303 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8303 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8303 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8403 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8403 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8403 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-8403 | FIRMAGON | Degarelix | Ferring Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61961 | SUPPL | 2020-02-26 |
| 61959 | SUPPL | 2020-02-25 |
| 38376 | SUPPL | 2015-11-04 |
| 7040 | SUPPL | 2015-10-28 |
| 17078 | SUPPL | 2015-03-03 |
| 7039 | SUPPL | 2015-02-27 |
| 38375 | SUPPL | 2013-08-21 |
| 29397 | SUPPL | 2013-08-20 |
| 17077 | SUPPL | 2013-03-08 |
| 29396 | SUPPL | 2013-03-06 |
| 42447 | ORIG | 2009-02-17 |
| 24258 | ORIG | 2009-02-17 |
| 7038 | ORIG | 2008-12-30 |
| 17076 | ORIG | 2008-12-29 |