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Details for New Drug Application (NDA): 022201
NDA 022201 describes FIRMAGON, which is a drug marketed by Ferring and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FIRMAGON profile page.
The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this compound. Additional details are available on the degarelix acetate profile page.
The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this compound. Additional details are available on the degarelix acetate profile page.
Summary for 022201
| Tradename: | FIRMAGON |
| Applicant: | Ferring |
| Ingredient: | degarelix acetate |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201 | NDA | Ferring Pharmaceuticals Inc. | 55566-8303 | N | 55566-8303-1 |
| FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201 | NDA | Ferring Pharmaceuticals Inc. | 55566-8403 | N | 55566-8403-1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 80MG BASE/VIAL | ||||
| Approval Date: | Dec 24, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 18, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Apr 27, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PROSTATE CANCER | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Feb 10, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT | ||||||||
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