Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021266
Company: PF PRISM CV
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VFEND | VORICONAZOLE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| VFEND | VORICONAZOLE | 200MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/24/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21266ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2022 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s054,021267s064,021630s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s054, 021267Orig1s064, 021630Orig1s043ltr.pdf | |
| 10/18/2022 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s053,021267s063,021630s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s053,021267Orig1s063,021630Orig1s042ltr.pdf | |
| 01/28/2022 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s052,021267s062,021630s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021266Orig1s052; 021267Orig1s062; 021630Orig1s041ltr.pdf | |
| 10/13/2021 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s051,021267s061,021630s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s051, 021267Orig1s061, 021630Orig1s040ltr.pdf | |
| 04/15/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s050,021267s060,021630s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s050; 021267Orig1s060; 021630Orig1s039ltr.pdf | |
| 01/25/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s049,021267s059,021630s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s049,021267Orig1s059,021630Orig1s038ltr.pdf | |
| 09/04/2020 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021266s048,021267s058,021630s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021266Orig1s048, 021267Orig1s058, 021630Orig1s037ltr.pdf | |
| 01/14/2021 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s047,021267s057,021630s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021266Orig1s047, 021267Orig1s057, 021630Orig1s036ltr.pdf | |
| 04/30/2019 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021630s034,021266s045,021267s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021266Orig1s045;021267Orig1s055;021630Orig1s034ltr.pdf | |
| 07/28/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s043,021267Orig1s054,021630Orig1s032ltr.pdf |
| 06/15/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021266Orig1s041,021267Orig1s053,021630Orig1s031ltr.pdf | |
| 01/29/2019 | SUPPL-39 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021266s039,021267s050,021630s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021266Orig1s039, 021267Orig1s050, 021630Oirg1s029ltr.pdf | |
| 02/03/2015 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf | |
| 04/07/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf | |
| 03/01/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/2011 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf | |
| 12/15/2010 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/01/2011 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf | |
| 11/21/2010 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf | |
| 12/15/2010 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf | |
| 06/17/2010 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf | |
| 06/17/2010 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf | |
| 06/17/2010 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf | |
| 05/30/2008 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf |
| 06/17/2010 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf | |
| 03/10/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf | |
| 12/15/2010 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/01/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf | |
| 05/19/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf | |
| 02/05/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s016ltr.pdf | |
| 03/10/2006 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf | |
| 12/18/2005 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf | |
| 07/07/2005 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf | |
| 03/24/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf | |
| 12/21/2004 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266Orig1s009.pdf | |
| 02/04/2004 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf | |
| 04/21/2004 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm | |
| 04/21/2004 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm | |
| 03/28/2003 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/18/2022 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s053,021267s063,021630s042lbl.pdf | |
| 08/16/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s054,021267s064,021630s043lbl.pdf | |
| 01/28/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021266s052,021267s062,021630s041lbl.pdf | |
| 10/13/2021 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s051,021267s061,021630s040lbl.pdf | |
| 04/15/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s050,021267s060,021630s039lbl.pdf | |
| 01/25/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s049,021267s059,021630s038lbl.pdf | |
| 01/14/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021266s047,021267s057,021630s036lbl.pdf | |
| 09/04/2020 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021266s048,021267s058,021630s037lbl.pdf | |
| 04/30/2019 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021630s034,021266s045,021267s055lbl.pdf | |
| 01/29/2019 | SUPPL-39 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021266s039,021267s050,021630s029lbl.pdf | |
| 07/28/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s043,021267s054,021630s032lbl.pdf |
| 06/15/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf | |
| 02/03/2015 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf | |
| 04/07/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf | |
| 11/16/2011 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf | |
| 06/01/2011 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf | |
| 12/15/2010 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf | |
| 11/21/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s032lbl.pdf | |
| 06/17/2010 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf | |
| 06/17/2010 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf | |
| 06/17/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf | |
| 06/17/2010 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf | |
| 03/10/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf | |
| 02/05/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf | |
| 12/01/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf | |
| 05/19/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf | |
| 03/10/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf | |
| 12/18/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf | |
| 07/07/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf | |
| 03/24/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf | |
| 12/21/2004 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf | |
| 04/21/2004 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf | |
| 04/21/2004 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf | |
| 02/04/2004 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf | |
| 03/28/2003 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf | |
| 05/24/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf |
VFEND
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 |