FDA.reportPublic FDA data

Application 019949

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLUCANFLUCONAZOLETABLET;ORAL50MGYesNo
002DIFLUCANFLUCONAZOLETABLET;ORAL100MGYesNo
003DIFLUCANFLUCONAZOLETABLET;ORAL200MGYesYes
004DIFLUCANFLUCONAZOLETABLET;ORAL150MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3410DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3420DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3430DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
0049-3500DiflucanfluconazoleRoerigNDACurrent
50436-5128FluconazolefluconazoleUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, InNDACurrent
55289-148DiflucanfluconazolePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED Current
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5015FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED Current
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED Current
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5017FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED Current
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5018FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
69189-5016FluconazolefluconazoleAvera McKennan HospitalNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77483SUPPL 2024-02-13
77479SUPPL 2024-02-13
74760SUPPL 2023-07-14
74749SUPPL 2023-07-13
73245SUPPL2023-01-18
73241SUPPL2023-01-18
70511SUPPL2022-03-15
70474SUPPL2022-03-10
69137SUPPL2021-10-27
69118SUPPL2021-10-26
64537SUPPL2020-09-10
64532SUPPL2020-09-09
57710SUPPL2019-02-20
57502SUPPL2019-02-12
52993SUPPL2018-03-15
52924SUPPL2018-03-13
51873SUPPL2018-01-26
51466SUPPL2018-01-23
50241SUPPL2017-10-31
50235SUPPL2017-10-30
34124SUPPL2014-11-04
19873SUPPL2014-10-31
12087SUPPL2014-03-25
1837SUPPL2014-03-25
12086SUPPL2013-09-17
1836SUPPL2013-09-17
34123SUPPL2011-11-21
19872SUPPL2011-11-21
19871SUPPL2011-06-08
34122SUPPL2011-06-06
12085SUPPL2011-04-29
1835SUPPL2011-04-29
19870SUPPL2010-08-10
12084SUPPL2010-08-10
34121SUPPL2008-04-16
19869SUPPL2008-04-04
34120SUPPL2004-10-08
34118SUPPL2004-10-08
34117SUPPL2004-10-08
19868SUPPL2004-10-08
19866SUPPL2004-10-08
19865SUPPL2004-10-08
12083SUPPL2004-04-05
1834SUPPL2004-03-28
34119SUPPL2002-08-07
19867SUPPL2002-08-07