Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210864
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SESQUIENT | FOSPHENYTOIN SODIUM | EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
SESQUIENT | FOSPHENYTOIN SODIUM | EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) | 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 |
---|---|---|---|---|---|---|---|
11/05/2020 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210864s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210864Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/210864Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/05/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210864s000lbl.pdf |