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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020140
Company: ACROTECH BIOPHARMA

Summary Review

Products on NDA 020140

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUSILEV	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes
FUSILEV	LEVOLEUCOVORIN CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
FUSILEV	LEVOLEUCOVORIN CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020140

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s000ltrCorrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140_levoleucovorin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2020	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020140Orig1s026ltr.pdf
02/11/2020	SUPPL-25	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020140Orig1s025ltr.pdf
01/08/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020140Orig1s024ltr.pdf
06/24/2014	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/09/2012	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/29/2011	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020140s002ltr.pdf
07/14/2008	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s001ltr.pdf

Labels for NDA 020140

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s026lbl.pdf
02/11/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s025lbl.pdf
02/11/2020	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s025lbl.pdf
01/08/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020140s024lbl.pdf
04/29/2011	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf
07/14/2008	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf
03/07/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf

Therapeutic Equivalents for NDA 020140

FUSILEV

POWDER;INTRAVENOUS; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FUSILEV	LEVOLEUCOVORIN CALCIUM	EQ 50MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	020140	ACROTECH BIOPHARMA

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