Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208574
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROMIDEPSIN | ROMIDEPSIN | 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
ROMIDEPSIN | ROMIDEPSIN | 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/13/2020 | ORIG-2 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm | |
03/13/2020 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208574Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/208574Orig1s000,Orig2s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2021 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208574Orig1s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/08/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208574s006lbl.pdf | |
03/13/2020 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574Orig2lbl.pdf | |
03/13/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208574s000lbl.pdf |