Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021630
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VFEND VORICONAZOLE 200MG/5ML FOR SUSPENSION;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
12/19/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21630_vfend_lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21630ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021630s000_VfendTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2018 SUPPL-33 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021630Orig1s033Ltr.pdf
07/28/2017 SUPPL-32 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-31 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
02/03/2015 SUPPL-28 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-27 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
11/16/2011 SUPPL-26 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
06/01/2011 SUPPL-24 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-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021630s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf
12/15/2010 SUPPL-22 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-21 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-20 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-18 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-15 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-14 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-13 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
12/01/2006 SUPPL-11 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-10 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-9 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/2008/021630s009ltr.pdf
03/10/2006 SUPPL-8 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-6 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-5 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-4 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-3 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/2004/021630Orig1s003.pdf
04/21/2004 SUPPL-1 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2017 SUPPL-32 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-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021266s041,021267s053,021630s031lbl.pdf
02/03/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf
04/07/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf
11/16/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf
06/01/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf
12/15/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf
11/21/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021630s023lbl.pdf
06/17/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf
06/17/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf
06/17/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf
06/17/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf
03/10/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf
02/05/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf
12/01/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf
05/19/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf
03/10/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf
12/18/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf
07/07/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf
03/24/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf
12/21/2004 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf
04/21/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf
12/19/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21630_vfend_lb.pdf

VFEND

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 206799 NOVEL LABS INC

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