Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204824
Company: ANTARES PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OTREXUP METHOTREXATE 10MG/0.4ML (10MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 15MG/0.4ML (15MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 20MG/0.4ML (20MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 25MG/0.4ML (25MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 7.5MG/0.4ML (7.5MG/0.4ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP METHOTREXATE 12.5MG/0.4ML (12.5MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 17.5MG/0.4ML (17.5MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP METHOTREXATE 22.5MG/0.4ML (22.5MG/0.4ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
OTREXUP PFS METHOTREXATE 10MG/0.4ML (10MG/0.4ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP PFS METHOTREXATE 15MG/0.6ML (15MG/0.6ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP PFS METHOTREXATE 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP PFS METHOTREXATE 20MG/0.8ML (20MG/0.8ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP PFS METHOTREXATE 22.5MG/0.9ML (22.5MG/0.9ML) SOLUTION;SUBCUTANEOUS Discontinued None Yes No
OTREXUP PFS METHOTREXATE 25MG/ML (25MG/ML) SOLUTION;SUBCUTANEOUS 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
10/11/2013 ORIG-2 Approval Efficacy STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig2s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm
10/11/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204824Orig1s009ltr.pdf
03/15/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204824s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2018/204824Orig1s008ltr.pdf
05/31/2017 SUPPL-6 Manufacturing (CMC)-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204824s006lbl.pdf
01/11/2017 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/24/2016 SUPPL-4 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf
11/07/2014 SUPPL-3 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204824Orig1s003ltr.pdf
10/08/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/07/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s009lbl.pdf
03/15/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204824s008lbl.pdf
05/31/2017 SUPPL-6 Manufacturing (CMC)-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204824s006lbl.pdf
03/24/2016 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf
11/07/2014 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf
10/11/2013 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig2s000Lbl.pdf
10/11/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000Lbl.pdf

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