Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211099
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2022 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/06/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 | 212162 | EUGIA PHARMA |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211099 | GLAND PHARMA LTD |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211661 | HAINAN POLY PHARM |
| 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 | 211264 | UBI |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208983 | ZYDUS PHARMS |