Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208400
Company: SILVERGATE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XATMEP METHOTREXATE SODIUM EQ 2MG BASE/ML SOLUTION;ORAL 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
04/25/2017 ORIG-2 Approval Efficacy STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.cfm
04/25/2017 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208400Orig1s000,208400Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208400Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/15/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208004s002lbl.pdf
04/25/2017 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf
04/25/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208400s000lbl.pdf

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