Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212479
Company: SHORLA
Company: SHORLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JYLAMVO | METHOTREXATE | 2MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
JYLAMVO | METHOTREXATE | 2MG/ML | SOLUTION;ORAL | Prescription | None | No | No |
JYLAMVO | METHOTREXATE | 2MG/ML | SOLUTION;ORAL | Prescription | None | No | No |
JYLAMVO | METHOTREXATE | 2MG/ML | SOLUTION;ORAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
11/29/2022 | ORIG-4 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.cfm | |
11/29/2022 | ORIG-3 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.cfm | |
11/29/2022 | ORIG-2 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.cfm | |
11/29/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212479Orig1s000; Orig2s000; Orig3s000; Orig4s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212479Orig1,Orig2,Orig3,Orig4s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/29/2022 | ORIG-4 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf | |
11/29/2022 | ORIG-3 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf | |
11/29/2022 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf | |
11/29/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf |