Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208562
Company: XELLIA PHARMS APS
Company: XELLIA PHARMS APS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
VORICONAZOLE | VORICONAZOLE | 200MG | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
---|---|---|---|---|---|---|---|
03/09/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208562s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208562Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208562Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2022 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208562s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208562Orig1s006ltr.pdf | |
01/03/2023 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208562s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208562Orig1s005ltr.pdf | |
12/17/2021 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208562s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208562Orig1s004ltr.pdf | |
03/26/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208562s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/03/2023 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208562s005lbl.pdf | |
08/16/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208562s006lbl.pdf | |
12/17/2021 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208562s004lbl.pdf | |
03/26/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208562s002lbl.pdf | |
03/09/2017 | ORIG-1 | Approval | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208562s000lbl.pdf |
VORICONAZOLE
INJECTABLE;INTRAVENOUS; 200MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VFEND | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021267 | PF PRISM CV |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206398 | ALMAJECT |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 218533 | ASPIRO |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211099 | GLAND PHARMA LTD |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 214516 | MEITHEAL |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090862 | SANDOZ INC |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211661 | SLATE RUN PHARMA |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211264 | UBI |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208562 | XELLIA PHARMS APS |
VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208983 | ZYDUS PHARMS |