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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022201

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FIRMAGON (DEGARELIX ACETATE)
EQ 80MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: DEGARELIX ACETATE
Proprietary Name: FIRMAGON
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 80MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022201
Product Number: 001
Approval Date: Dec 24, 2008
Applicant Holder Full Name: FERRING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FIRMAGON (DEGARELIX ACETATE)
EQ 120MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: DEGARELIX ACETATE
Proprietary Name: FIRMAGON
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 120MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022201
Product Number: 002
Approval Date: Dec 24, 2008
Applicant Holder Full Name: FERRING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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