Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217512
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | EQ 80MG BASE/100ML (EQ 0.8MG BASE/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 |
---|---|---|---|---|---|---|---|
02/14/2024 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217512s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217512Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/14/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217512s000lbl.pdf |