Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216142
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | EQ 50MG BASE/50ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | EQ 100MG BASE/100ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | EQ 150MG BASE/150ML (EQ 1MG 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 |
|---|---|---|---|---|---|---|---|
| 09/29/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216142s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216142Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216142Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/29/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216142s000lbl.pdf |