Application 021630

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VFEND	VORICONAZOLE	FOR SUSPENSION;ORAL	200MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021630-001	VFEND	VORICONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021630-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021630-001	VFEND	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2003-12-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021630-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021630-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021630-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021630-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021630-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021630-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021630-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021630-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021630-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021630-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021630-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021630-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021630-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021630-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021630-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021630-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021630-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021630-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021630-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021630-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021630-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021630-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021630-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021630-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021630-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021630-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021630-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021630-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021630-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021630-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021630-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021630-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021630-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021630-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021630-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021630-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021630-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021630-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021630-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021630-001	AB	1	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021630-001	NPP	2022-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021630-001	NPP	2022-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021630-001	NPP	2022-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021630-001	NPP	2022-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021630-001	NPP	2022-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021630-001	NPP	2022-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021630-001	NPP	2022-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021630-001	NPP	2022-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021630-001	NPP	2022-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021630-001	NPP	2022-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021630-001	NPP	2022-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021630-001	NPP	2022-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021630-001	NPP	2022-01-29	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021630-001	NPP	2022-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021630-001	NPP	2022-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021630-001	NPP	2022-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021630-001	NPP	2022-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021630-001	NPP	2022-01-29	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	b8de04a0-238d-4e0b-b0d9-7f7878b149d4	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021630 application number: NDA021630 ndc (product): 59762-0935
VFEND	VORICONAZOLE	Roerig	ce3ef5cf-3087-4d92-9d94-9eb8287228db	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021630 application number: NDA021630 ndc (product): 0049-3160

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
0049-3160	VFEND	voriconazole	Roerig	NDA	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0935	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85127	SUPPL	2026-02-24
85106	SUPPL	2026-02-23
84878	SUPPL	2026-01-29
84871	SUPPL	2026-01-29
81577	SUPPL	2025-03-17
81560	SUPPL	2025-03-14
79511	SUPPL	2024-09-02
79484	SUPPL	2024-08-27
72433	SUPPL	2022-10-21
72410	SUPPL	2022-10-19
71832	SUPPL	2022-08-17
71820	SUPPL	2022-08-17
70032	SUPPL	2022-02-01
70014	SUPPL	2022-01-31
68997	SUPPL	2021-10-14
68985	SUPPL	2021-10-14
67096	SUPPL	2021-04-19
67093	SUPPL	2021-04-19
65995	SUPPL	2021-01-26
65981	SUPPL	2021-01-26
65980	SUPPL	2021-01-26
65929	SUPPL	2021-01-19
64528	SUPPL	2020-09-08
64523	SUPPL	2020-09-08
58519	SUPPL	2019-05-02
58496	SUPPL	2019-04-30
57559	SUPPL	2019-02-13
57382	SUPPL	2019-01-30
55888	SUPPL	2018-10-11
49189	SUPPL	2017-08-02
49159	SUPPL	2017-07-31
48764	SUPPL	2017-06-19
48740	SUPPL	2017-06-16
37367	SUPPL	2015-02-05
28279	SUPPL	2015-02-05
37366	SUPPL	2014-04-08
28278	SUPPL	2014-04-08
42243	SUPPL	2012-11-09
15900	SUPPL	2011-11-21
5889	SUPPL	2011-11-21
37365	SUPPL	2011-06-16
28277	SUPPL	2011-06-02
15899	SUPPL	2010-12-26
28275	SUPPL	2010-12-21
28276	SUPPL	2010-11-30
37364	SUPPL	2010-11-21
37363	SUPPL	2010-06-24
37362	SUPPL	2010-06-24
28274	SUPPL	2010-06-24
28272	SUPPL	2010-06-24
15898	SUPPL	2010-06-24
15897	SUPPL	2010-06-24
5888	SUPPL	2010-06-24
5887	SUPPL	2010-06-24
28273	SUPPL	2008-06-03
37361	SUPPL	2008-03-13
28271	SUPPL	2008-03-13
15896	SUPPL	2008-02-14
28269	SUPPL	2008-02-07
42242	SUPPL	2007-01-10
5886	SUPPL	2006-12-28
37360	SUPPL	2006-12-04
42241	ORIG	2006-07-25
37359	SUPPL	2006-05-22
28270	SUPPL	2006-05-22
15895	SUPPL	2006-03-22
5885	SUPPL	2006-03-22
28268	SUPPL	2006-01-19
15894	SUPPL	2006-01-05
28267	SUPPL	2005-07-15
15893	SUPPL	2005-07-08
15892	SUPPL	2005-03-29
5884	SUPPL	2005-03-29
37358	SUPPL	2004-12-29
5883	SUPPL	2004-12-29
15891	SUPPL	2004-05-04
5882	SUPPL	2004-04-29
37357	ORIG	2003-12-29
5881	ORIG	2003-12-24