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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 021506


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NDA 021506 describes MYCAMINE, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. Additional details are available on the MYCAMINE profile page.

The generic ingredient in MYCAMINE is micafungin sodium. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 021506
Tradename:MYCAMINE
Applicant:Astellas
Ingredient:micafungin sodium
Patents:0
Pharmacology for NDA: 021506
Suppliers and Packaging for NDA: 021506
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506 NDA Astellas Pharma US, Inc. 0469-3211 0469-3211-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) / 10 mL in 1 VIAL, SINGLE-DOSE
MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506 NDA Astellas Pharma US, Inc. 0469-3250 0469-3250-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Mar 16, 2005TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:Jun 27, 2006TE:APRLD:Yes

Expired US Patents for NDA 021506

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ⤷  Sign Up ⤷  Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ⤷  Sign Up ⤷  Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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