Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022468
Company: ACROTECH BIOPHARMA
Company: ACROTECH BIOPHARMA
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 |
---|---|---|---|---|---|
10/20/2020 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022468Orig1s014ltr.pdf | |
05/14/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022468Orig1s013ltr.pdf | |
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 |
---|---|---|---|---|---|
10/20/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s014lbl.pdf | |
05/14/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022468s013lbl.pdf | |
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 |