An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Discontinued	None	Yes	No
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CALCIUM	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No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CALCIUM	EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No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.html 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

Top