Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208171

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MONOFERRIC (FERRIC DERISOMALTOSE)
1GM/10ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: FERRIC DERISOMALTOSE
Proprietary Name: MONOFERRIC
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208171
Product Number: 003
Approval Date: Jan 16, 2020
Applicant Holder Full Name: PHARMACOSMOS AS
Marketing Status:  Prescription
Patent and Exclusivity Information

MONOFERRIC (FERRIC DERISOMALTOSE)
100MG/ML (100MG/ML)
Marketing Status: Discontinued

Active Ingredient: FERRIC DERISOMALTOSE
Proprietary Name: MONOFERRIC
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208171
Product Number: 001
Approval Date: Jan 16, 2020
Applicant Holder Full Name: PHARMACOSMOS AS
Marketing Status:  Discontinued
Patent and Exclusivity Information

MONOFERRIC (FERRIC DERISOMALTOSE)
500MG/5ML (100MG/ML)
Marketing Status: Discontinued

Active Ingredient: FERRIC DERISOMALTOSE
Proprietary Name: MONOFERRIC
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/5ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208171
Product Number: 002
Approval Date: Jan 16, 2020
Applicant Holder Full Name: PHARMACOSMOS AS
Marketing Status:  Discontinued
Patent and Exclusivity Information