Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021266
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
07/28/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
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
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
07/28/2017 SUPPL-43 Labeling-Package Insert Label (PDF) 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 207049 AKORN
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206762 APPCO PHARMA LLC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206837 AUROBINDO PHARMA LTD
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 207371 NOVEL LABS INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206654 PRINSTON INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 200265 SANDOZ INC
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 091658 TEVA PHARMS
VORICONAZOLE VORICONAZOLE 50MG TABLET;ORAL Prescription No AB 206747 ZYDUS PHARMS USA 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 207049 AKORN
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206762 APPCO PHARMA LLC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206837 AUROBINDO PHARMA LTD
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 207371 NOVEL LABS INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206654 PRINSTON INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 200265 SANDOZ INC
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 091658 TEVA PHARMS
VORICONAZOLE VORICONAZOLE 200MG TABLET;ORAL Prescription No AB 206747 ZYDUS PHARMS USA INC

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