Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021001
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AXERT | ALMOTRIPTAN MALATE | EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
AXERT | ALMOTRIPTAN MALATE | EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/07/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/13/2009 | SUPPL-18 |
Label is not available on this site. |
|||
05/15/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021001s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021001Orig1s015ltr.pdf | |
08/07/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021001Orig1s014ltr.pdf | |
04/30/2009 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf | |
04/30/2009 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s010,s011ltr.pdf | |
03/27/2009 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf | |
03/27/2009 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf | |
06/01/2004 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21001slr002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/15/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021001s015lbl.pdf | |
08/07/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf | |
04/30/2009 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf | |
04/30/2009 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf | |
03/27/2009 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf | |
03/27/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf | |
05/07/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf |