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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 020140

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NDA 020140 describes FUSILEV, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. 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. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for 020140

Tradename:	FUSILEV
Applicant:	Acrotech Biopharma
Ingredient:	levoleucovorin calcium
Patents:	0

Pharmacology for NDA: 020140

Medical Subject Heading (MeSH) Categories for 020140

Antidotes

Suppliers and Packaging for NDA: 020140

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140	NDA	Acrotech Biopharma Inc	72893-009	72893-009-01	1 VIAL in 1 CARTON (72893-009-01) / 5 mL in 1 VIAL
FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140	NDA	Acrotech Biopharma Inc	72893-009	72893-009-01	1 VIAL in 1 CARTON (72893-009-01) / 5 mL in 1 VIAL

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 29, 2011	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 29, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 020140

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	⤷ Try a Trial	⤷ Try a Trial
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008	⤷ Try a Trial	⤷ Try a Trial
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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