Application 020090

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIFLUCAN	FLUCONAZOLE	FOR SUSPENSION;ORAL	50MG/5ML	Yes	No
002	DIFLUCAN	FLUCONAZOLE	FOR SUSPENSION;ORAL	200MG/5ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020090-001	DIFLUCAN	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23
N020090-002	DIFLUCAN	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020090-001	AB
N020090-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020090-001	DIFLUCAN	50MG/5ML	FOR SUSPENSION / ORAL	AB	RLD	1993-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020090-002	DIFLUCAN	200MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1993-12-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020090-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020090-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020090-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020090-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020090-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020090-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020090-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020090-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020090-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020090-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020090-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020090-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020090-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020090-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020090-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020090-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020090-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020090-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020090-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020090-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020090-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020090-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020090-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020090-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020090-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020090-002	AB	1	`782e0a99824c…`

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
Fluconazole	FLUCONAZOLE	Mylan Pharmaceuticals Inc.	737e0fac-a2d2-4053-a0d7-edbfb6248f69	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020090 application number: NDA020090 ndc (product): 59762-5029 ndc (product): 59762-5030
Diflucan	FLUCONAZOLE	Roerig	f694c617-3383-416c-91b6-b94fda371204	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020090 application number: NDA020090 ndc (product): 0049-3440 ndc (product): 0049-3450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3440	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
0049-3450	Diflucan	fluconazole	Roerig	NDA	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5029	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5030	Fluconazole	fluconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77498	SUPPL	2024-02-14
77481	SUPPL	2024-02-13
74761	SUPPL	2023-07-14
74751	SUPPL	2023-07-13
73246	SUPPL	2023-01-18
73243	SUPPL	2023-01-18
70513	SUPPL	2022-03-15
70477	SUPPL	2022-03-10
69139	SUPPL	2021-10-27
69120	SUPPL	2021-10-26
64536	SUPPL	2020-09-10
64534	SUPPL	2020-09-09
57711	SUPPL	2019-02-20
57525	SUPPL	2019-02-13
52994	SUPPL	2018-03-15
52925	SUPPL	2018-03-13
51898	SUPPL	2018-01-26
51872	SUPPL	2018-01-26
51467	SUPPL	2018-01-23
50242	SUPPL	2017-10-31
50234	SUPPL	2017-10-30
12209	SUPPL	2014-11-04
2013	SUPPL	2014-10-31
12208	SUPPL	2014-03-25
2012	SUPPL	2014-03-25
34256	SUPPL	2013-09-17
21143	SUPPL	2013-09-17
21142	SUPPL	2011-11-21
12207	SUPPL	2011-11-21
21141	SUPPL	2011-06-08
12206	SUPPL	2011-06-06
34255	SUPPL	2011-04-29
2011	SUPPL	2011-04-29
21140	SUPPL	2010-08-10
12205	SUPPL	2010-08-10
12204	SUPPL	2008-04-16
2010	SUPPL	2008-04-04
34254	SUPPL	2004-10-08
34253	SUPPL	2004-10-08
21138	SUPPL	2004-10-08
21137	SUPPL	2004-10-08
12201	SUPPL	2004-10-08
2008	SUPPL	2004-10-08
12203	SUPPL	2004-04-05
21139	SUPPL	2004-03-28
12202	SUPPL	2002-08-07
2009	SUPPL	2002-08-07