Details for New Drug Application (NDA): 204246
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NDA 204246 describes FYREMADEL, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the FYREMADEL profile page.
The generic ingredient in FYREMADEL is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
The generic ingredient in FYREMADEL is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
Summary for 204246
| Tradename: | FYREMADEL |
| Applicant: | Sun Pharm |
| Ingredient: | ganirelix acetate |
| Patents: | 0 |
Pharmacology for NDA: 204246
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Antagonists |
| Physiological Effect | Decreased GnRH Secretion |
Suppliers and Packaging for NDA: 204246
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FYREMADEL | ganirelix acetate | INJECTABLE;INJECTION | 204246 | ANDA | Ferring Pharmaceuticals Inc. | 55566-1010 | 55566-1010-1 | 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MCG/0.5ML | ||||
| Approval Date: | Nov 30, 2018 | TE: | AP | RLD: | No | ||||
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