Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022468
Company: ACROTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOLOTYN PRALATREXATE 20MG/ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes No
FOLOTYN PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/2009 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022468s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022468s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022468Orig1s012ltr.pdf
05/30/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
05/30/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s010,s011ltr.pdf
02/15/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022468s009ltr.pdf
01/07/2011 SUPPL-5 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
01/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
01/07/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022468s003,s004,s005ltr.pdf
04/26/2010 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022468s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/13/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022468s012lbl.pdf
05/30/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
05/30/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s010s011lbl.pdf
02/15/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022468s009lbl.pdf
01/07/2011 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
01/07/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
01/07/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022468s003s004s005lbl.pdf
04/26/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022468s001lbl.pdf
09/24/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022468lbl.pdf

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