Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208419
Company: ACTAVIS
Company: ACTAVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEMETREXED | PEMETREXED | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PEMETREXED | PEMETREXED | 500MG/20ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PEMETREXED | PEMETREXED | 1GM/40ML (25MG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
08/21/2020 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208419s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208419Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208419Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2022 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s004ltr.pdf | |
11/22/2022 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s003ltr.pdf | |
11/22/2022 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208419Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/22/2022 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s004lbl.pdf | |
11/22/2022 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s003lbl.pdf | |
11/22/2022 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208419s002lbl.pdf | |
08/21/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208419s000lbl.pdf |