Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022161
Company: ASTELLAS
Company: ASTELLAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEXISCAN | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/10/2008 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022161s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022161s000_LexiscanTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2018 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022161s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022161Orig1s015ltr.pdf | |
01/17/2017 | SUPPL-13 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022161s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022161Orig1s013ltr.pdf | |
09/19/2014 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s012ltr.pdf | |
01/09/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.pdf | |
09/30/2011 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s009ltr.pdf | |
09/23/2011 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf | |
09/23/2011 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf | |
09/23/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf | |
03/29/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/2009 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s004ltr.pdf | |
03/17/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/31/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022161s015lbl.pdf | |
01/17/2017 | SUPPL-13 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022161s013lbl.pdf | |
09/19/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf | |
01/09/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf | |
01/09/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf | |
09/30/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf | |
09/23/2011 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf | |
09/23/2011 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf | |
09/23/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf | |
12/23/2009 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf | |
03/17/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf | |
04/10/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf |
LEXISCAN
SOLUTION;INTRAVENOUS; 0.4MG/5ML (0.08MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEXISCAN | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022161 | ASTELLAS |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213236 | ACCORD HLTHCARE |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207604 | APOTEX |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217455 | BAXTER HLTHCARE CORP |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213210 | DR REDDYS |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216437 | EUGIA PHARMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215955 | GE HEALTHCARE |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207320 | GLAND PHARMA LTD |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215827 | HIKMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214349 | HOSPIRA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214252 | IMS LTD |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218054 | INDIES PHARMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212806 | MEITHEAL |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213856 | MYLAN |