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:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Mar 16, 2005	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG BASE/VIAL
Approval Date:	Jun 27, 2006	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021506

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,107,458	⤷ Subscribe
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	5,376,634	⤷ Subscribe
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,265,536	⤷ Subscribe
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	5,376,634	⤷ Subscribe
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