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

NDC Listings For This Application#

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 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	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

Application 020090

Related Records#

Application Products#

NDC Listings For This Application#

Documents#