Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090862
Company: SANDOZ INC
Company: SANDOZ INC
| 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090862Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/23/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/23/2015 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient 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 | ALVOGEN |
| 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 | 090862 | SANDOZ INC |
| VORICONAZOLE | VORICONAZOLE | 200MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 208983 | ZYDUS PHARMS |
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