Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208400
Company: AZURITY
Company: AZURITY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XATMEP | METHOTREXATE SODIUM | EQ 2.5MG 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 |