Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210737
Company: NORDIC GRP
Company: NORDIC GRP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REDITREX | METHOTREXATE | 7.5MG/0.3ML (7.5MG/0.3ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 10MG/0.4ML (10MG/0.4ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 15MG/0.6ML (15MG/0.6ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 17.5MG/0.7ML (17.5MG/0.7ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 20MG/0.8ML (20MG/0.8ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 22.5MG/ML (22.5MG/ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
REDITREX | METHOTREXATE | 25MG/1ML (25MG/1ML) | 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 |
---|---|---|---|---|---|---|---|
11/27/2019 | ORIG-2 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm | |
11/27/2019 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210737Orig1s000,Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210737Orig1s000, 210737Orig2s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/30/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210737Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/30/2023 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf | |
03/30/2023 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210737s002lbl.pdf | |
11/27/2019 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf | |
11/27/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210737s000lbl.pdf |