Application 019949

Type
NDA
Sponsor
PFIZER

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019949-001DIFLUCANFLUCONAZOLE50MGTABLET / ORALABRLD1990-01-29
N019949-002DIFLUCANFLUCONAZOLE100MGTABLET / ORALABRLD1990-01-29
N019949-003DIFLUCANFLUCONAZOLE200MGTABLET / ORALABRLD, RS1990-01-29
N019949-004DIFLUCANFLUCONAZOLE150MGTABLET / ORALABRLD1994-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N019949-001AB
N019949-002AB
N019949-003AB
N019949-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-001DIFLUCAN50MGTABLET / ORALABRLD1990-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-002DIFLUCAN100MGTABLET / ORALABRLD1990-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-003DIFLUCAN200MGTABLET / ORALABRLD, RS1990-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-004DIFLUCAN150MGTABLET / ORALABRLD1994-06-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019949-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019949-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019949-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019949-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019949-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019949-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019949-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019949-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019949-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019949-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019949-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019949-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019949-004AB1d8e5a09893c0…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEMylan Pharmaceuticals Inc.737e0fac-a2d2-4053-a0d7-edbfb6248f692026-04-02Warnings, Adverse reactionsExact identifier
ndc (product): 59762-5015
ndc (product): 59762-5016
ndc (product): 59762-5017
ndc (product): 59762-5018
DiflucanFLUCONAZOLERoerigf694c617-3383-416c-91b6-b94fda3712042026-04-02Warnings, Adverse reactionsExact identifier
ndc (product): 0049-3420
ndc (product): 0049-3500
ndc (product): 0049-3410
ndc (product): 0049-3430

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 78 matching rows.

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, InNDACurrent
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, 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 Current
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5016FluconazolefluconazoleGreenstone LLCNDA AUTHORIZED GENERICCurrent
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 Current
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
59762-5018FluconazolefluconazoleGreenstone 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