Details for New Drug Application (NDA): 020140

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NDA 020140 describes FUSILEV, which is a drug marketed by Acrotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the FUSILEV profile page.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for 020140

Tradename:	FUSILEV
Applicant:	Acrotech
Ingredient:	levoleucovorin calcium
Patents:	1

Medical Subject Heading (MeSH) Categories for 020140

Antidotes

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Mar 7, 2008	TE:	AP	RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Mar 7, 2022	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:	Apr 29, 2011	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Mar 7, 2022	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date:	Apr 29, 2011	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Mar 7, 2022	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 020140

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	See Plans and Pricing	See Plans and Pricing
Acrotech	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008	See Plans and Pricing	See Plans and Pricing
Acrotech	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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