Fyremadel is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is Ganirelix Acetate.
Product ID | 55566-1010_4f2833c9-d086-43c5-83d3-17d9986a7a3e |
NDC | 55566-1010 |
Product Type | Human Prescription Drug |
Proprietary Name | Fyremadel |
Generic Name | Ganirelix Acetate |
Dosage Form | Injection, Solution |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2021-12-14 |
Marketing Category | ANDA / |
Application Number | ANDA204246 |
Labeler Name | Ferring Pharmaceuticals Inc. |
Substance Name | GANIRELIX ACETATE |
Active Ingredient Strength | 250 ug/.5mL |
Pharm Classes | Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Receptor Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2021-12-14 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
55566-1010 | Fyremadel | ganirelix acetate |
0052-0301 | Ganirelix Acetate | Ganirelix Acetate |
0548-5001 | Ganirelix Acetate | Ganirelix Acetate |
55566-1000 | Ganirelix Acetate | Ganirelix Acetate |
62756-072 | Ganirelix Acetate | Ganirelix Acetate |
71288-554 | Ganirelix Acetate | Ganirelix Acetate |
78206-138 | Ganirelix Acetate | Ganirelix Acetate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FYREMADEL 88221016 not registered Live/Pending |
Ferring B.V. 2018-12-07 |