FDA.reportPublic FDA data

Application 021630

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VFENDVORICONAZOLEFOR SUSPENSION;ORAL200MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
0049-3160VFENDvoriconazoleRoerigNDACurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDACurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDACurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDACurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0935VoriconazoleVoriconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85127SUPPL 2026-02-24
85106SUPPL 2026-02-23
84878SUPPL 2026-01-29
84871SUPPL 2026-01-29
81577SUPPL 2025-03-17
81560SUPPL 2025-03-14
79511SUPPL 2024-09-02
79484SUPPL 2024-08-27
72433SUPPL2022-10-21
72410SUPPL2022-10-19
71832SUPPL2022-08-17
71820SUPPL2022-08-17
70032SUPPL2022-02-01
70014SUPPL2022-01-31
68997SUPPL2021-10-14
68985SUPPL2021-10-14
67096SUPPL2021-04-19
67093SUPPL2021-04-19
65995SUPPL2021-01-26
65981SUPPL2021-01-26
65980SUPPL2021-01-26
65929SUPPL2021-01-19
64528SUPPL2020-09-08
64523SUPPL2020-09-08
58519SUPPL2019-05-02
58496SUPPL2019-04-30
57559SUPPL2019-02-13
57382SUPPL2019-01-30
55888SUPPL2018-10-11
49189SUPPL2017-08-02
49159SUPPL2017-07-31
48764SUPPL2017-06-19
48740SUPPL2017-06-16
37367SUPPL2015-02-05
28279SUPPL2015-02-05
37366SUPPL2014-04-08
28278SUPPL2014-04-08
42243SUPPL2012-11-09
15900SUPPL2011-11-21
5889SUPPL2011-11-21
37365SUPPL2011-06-16
28277SUPPL2011-06-02
15899SUPPL2010-12-26
28275SUPPL2010-12-21
28276SUPPL2010-11-30
37364SUPPL2010-11-21
37363SUPPL2010-06-24
37362SUPPL2010-06-24
28274SUPPL2010-06-24
28272SUPPL2010-06-24
15898SUPPL2010-06-24
15897SUPPL2010-06-24
5888SUPPL2010-06-24
5887SUPPL2010-06-24
28273SUPPL2008-06-03
37361SUPPL2008-03-13
28271SUPPL2008-03-13
15896SUPPL2008-02-14
28269SUPPL2008-02-07
42242SUPPL2007-01-10
5886SUPPL2006-12-28
37360SUPPL2006-12-04
42241ORIG2006-07-25
37359SUPPL2006-05-22
28270SUPPL2006-05-22
15895SUPPL2006-03-22
5885SUPPL2006-03-22
28268SUPPL2006-01-19
15894SUPPL2006-01-05
28267SUPPL2005-07-15
15893SUPPL2005-07-08
15892SUPPL2005-03-29
5884SUPPL2005-03-29
37358SUPPL2004-12-29
5883SUPPL2004-12-29
15891SUPPL2004-05-04
5882SUPPL2004-04-29
37357ORIG2003-12-29
5881ORIG2003-12-24