Application 021267

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VFENDVORICONAZOLEINJECTABLE;INTRAVENOUS200MG/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021267-001VFENDVORICONAZOLE200MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2002-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021267-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021267-001VFEND200MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2002-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021267-001VFEND200MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2002-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-243f01610625f2…
2019-09-15 20:21 UTC2019-09N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021267-001VFEND200MG/VIALINJECTABLE / INTRAVENOUSAPRLD, RS2002-05-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021267-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021267-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021267-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021267-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021267-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021267-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021267-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021267-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021267-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021267-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021267-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021267-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021267-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021267-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021267-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021267-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021267-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021267-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021267-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021267-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021267-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021267-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021267-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021267-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021267-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021267-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021267-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021267-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021267-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021267-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021267-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021267-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021267-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021267-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021267-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021267-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021267-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021267-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021267-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021267-001AP1cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021267-001NPP2022-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021267-001NPP2022-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021267-001NPP2022-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021267-001NPP2022-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021267-001NPP2022-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021267-001NPP2022-01-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021267-001NPP2022-01-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021267-001NPP2022-01-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021267-001NPP2022-01-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021267-001NPP2022-01-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021267-001NPP2022-01-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021267-001NPP2022-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021267-001NPP2022-01-29ea99ee380514…
2023-01-26 05:58 UTC2023-01N021267-001NPP2022-01-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021267-001NPP2022-01-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021267-001NPP2022-01-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021267-001NPP2022-01-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021267-001NPP2022-01-29cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VFENDVORICONAZOLERoerig08d08721-1f4c-478a-8abf-d9c402d505532026-03-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021267
application number: NDA021267
ndc (product): 0049-4190
VFENDVORICONAZOLERoerigdac26bcd-7a59-401f-9f66-a0649767cece2026-03-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021267
application number: NDA021267
ndc (product): 0049-3190
VFENDVORICONAZOLERoerigce3ef5cf-3087-4d92-9d94-9eb8287228db2026-02-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021267
application number: NDA021267
ndc (product): 0049-3190

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDVoriconazoleRoerigNDACurrent
0049-3190VFENDvoriconazoleRoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent
0049-4190VFENDVORICONAZOLERoerigNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85126SUPPL 2026-02-24
85105SUPPL 2026-02-23
84876SUPPL 2026-01-29
84870SUPPL 2026-01-29
81576SUPPL 2025-03-17
81559SUPPL 2025-03-14
72432SUPPL2022-10-21
72409SUPPL2022-10-19
71831SUPPL2022-08-17
71819SUPPL2022-08-17
70031SUPPL2022-02-01
70013SUPPL2022-01-31
68996SUPPL2021-10-14
68984SUPPL2021-10-14
67095SUPPL2021-04-19
67092SUPPL2021-04-19
65994SUPPL2021-01-26
65983SUPPL2021-01-26
65979SUPPL2021-01-26
65928SUPPL2021-01-19
64527SUPPL2020-09-08
64522SUPPL2020-09-08
58518SUPPL2019-05-02
58498SUPPL2019-05-01
57558SUPPL2019-02-13
57381SUPPL2019-01-30
49188SUPPL2017-08-02
49158SUPPL2017-07-31
48763SUPPL2017-06-19
48741SUPPL2017-06-16
36524SUPPL2015-02-05
27294SUPPL2015-02-05
36523SUPPL2014-04-08
4847SUPPL2014-04-08
42065SUPPL2012-11-09
36522SUPPL2011-11-21
27293SUPPL2011-11-21
14812SUPPL2011-06-16
27292SUPPL2011-06-02
36520SUPPL2010-12-26
27290SUPPL2010-12-21
27291SUPPL2010-11-30
36521SUPPL2010-11-21
36519SUPPL2010-06-24
36518SUPPL2010-06-24
27289SUPPL2010-06-24
27288SUPPL2010-06-24
14811SUPPL2010-06-24
14810SUPPL2010-06-24
4846SUPPL2010-06-24
4845SUPPL2010-06-24
27287SUPPL2008-06-03
27286SUPPL2008-03-13
14809SUPPL2008-03-13
14807SUPPL2008-02-14
27283SUPPL2008-02-07
42064SUPPL2007-01-10
21560SUPPL2007-01-10
27285SUPPL2006-12-28
36517SUPPL2006-12-04
27284SUPPL2006-05-22
14808SUPPL2006-05-22
27282SUPPL2006-03-22
14806SUPPL2006-03-22
4844SUPPL2006-01-19
14805SUPPL2006-01-05
27281SUPPL2005-07-15
14804SUPPL2005-07-08
27280SUPPL2005-03-29
14803SUPPL2005-03-29
36516SUPPL2004-12-29
27279SUPPL2004-12-29
14799ORIG2004-06-30
4840ORIG2004-06-30
36515SUPPL2004-05-04
14801SUPPL2004-05-04
27278SUPPL2004-04-29
4842SUPPL2004-04-29
14802SUPPL2004-03-03
4843SUPPL2004-02-27
21559ORIG2003-12-02
4841SUPPL2003-04-14
14800SUPPL2003-03-28
63271ORIG1900-01-01
63270ORIG1900-01-01
63269ORIG1900-01-01
63268ORIG1900-01-01