Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020140
Company: ACROTECH
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CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No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CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 206516 ACTAVIS LLC
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 207547 AMNEAL PHARMS CO
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 211003 NANJING KING-FRIEND
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 206263 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English