Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090547
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/22/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090547s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/23/2025 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-15 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/12/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2016 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/27/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
VORICONAZOLE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VFEND | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021266 | PF PRISM CV |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206181 | AJANTA PHARMA LTD |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206837 | AUROBINDO PHARMA LTD |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206747 | CADILA |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 207371 | CHARTWELL RX |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 207049 | EPIC PHARMA LLC |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 203503 | GLENMARK PHARMS LTD |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 090547 | MYLAN PHARMS INC |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206654 | PRINSTON INC |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206762 | RISING |
| VORICONAZOLE | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 200265 | SANDOZ INC |
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VFEND | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 021266 | PF PRISM CV |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 206181 | AJANTA PHARMA LTD |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 206837 | AUROBINDO PHARMA LTD |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 206747 | CADILA |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 207371 | CHARTWELL RX |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 207049 | EPIC PHARMA LLC |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 203503 | GLENMARK PHARMS LTD |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 090547 | MYLAN PHARMS INC |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 206654 | PRINSTON INC |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 206762 | RISING |
| VORICONAZOLE | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 200265 | SANDOZ INC |