Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205034
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/13/2016 | 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 |
|---|---|---|---|---|---|
| 06/15/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/15/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
VORICONAZOLE
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VFEND | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021630 | PF PRISM CV |
| VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205034 | AMNEAL PHARMS |
| VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211598 | HETERO LABS LTD V |
| VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 206799 | NOVEL LABS INC |
| VORICONAZOLE | VORICONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 216805 | ZHEJIANG POLY PHARM |