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Details for New Drug Application (NDA): 022201

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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 two 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.

Summary for NDA: 022201

Tradename:
FIRMAGON
Applicant:
Ferring
Ingredient:
degarelix acetate
Patents:2
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 55566-8303-1 1 KIT in 1 CARTON (55566-8303-1) * 4 mL in 1 VIAL, GLASS * 4.2 mL in 1 SYRINGE
FIRMAGON
degarelix acetate
POWDER;SUBCUTANEOUS 022201 NDA Ferring Pharmaceuticals Inc. 55566-8403 55566-8403-1 1 KIT in 1 CARTON (55566-8403-1) * 3 mL in 1 VIAL, GLASS * 3 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 80MG BASE/VIAL
Approval Date:Dec 24, 2008TE:RLD:No
Patent:9,415,085Patent Expiration:Apr 27, 2032Product Flag?Substance Flag?Delist Request?
Patent:5,925,730Patent Expiration:May 18, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 120MG BASE/VIAL
Approval Date:Dec 24, 2008TE:RLD:Yes
Patent:9,415,085Patent Expiration:Apr 27, 2032Product Flag?Substance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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