Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021506

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MYCAMINE (MICAFUNGIN SODIUM)
EQ 50MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MYCAMINE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021506
Product Number: 002
Approval Date: Mar 16, 2005
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MYCAMINE (MICAFUNGIN SODIUM)
EQ 100MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: MICAFUNGIN SODIUM
Proprietary Name: MYCAMINE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021506
Product Number: 003
Approval Date: Jun 27, 2006
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information