Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206398
Company: ALVOGEN
Company: ALVOGEN
| 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 |
|---|---|---|---|---|---|---|---|
| 03/23/2016 | ORIG-1 | Approval | STANDARD |
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 | ALVOGEN |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 211661 | HAINAN POLY PHARM |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090862 | SANDOZ INC |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208983 | ZYDUS PHARMS |
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