Application 078423

Type
ANDA
Sponsor
HARRIS PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo

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

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
A078423-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2011-03-07
A078423-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2011-03-07
A078423-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2011-03-07
A078423-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2011-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078423-001AB
A078423-002AB
A078423-003AB
A078423-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078423-001FLUCONAZOLE50MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-002FLUCONAZOLE100MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-003FLUCONAZOLE150MGTABLET / ORALAB2011-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-004FLUCONAZOLE200MGTABLET / ORALAB2011-03-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078423-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078423-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078423-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078423-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078423-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078423-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078423-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078423-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078423-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078423-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078423-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078423-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078423-004AB1d06236e962d9…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEREMEDYREPACK INC.91adb548-9875-47e9-8054-578ed8c7572e2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEGolden State Medical Supply, Inc.c2c7242d-d172-4733-e053-2995a90acb2e2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 51407-426
ndc (product): 51407-427
ndc (product): 51407-425
ndc (product): 51407-424
FluconazoleFLUCONAZOLEBryant Ranch Prepack2c9abaee-461f-437d-adda-e96d7ae3dd012026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEA-S Medication Solutionsa0f1c111-e11e-4b7e-b990-8bc271cbc9402026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepack701cd91f-4f79-48a7-8fe5-a9678d7a4ac82025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEANI Pharmaceuticals, Inc.8f90f169-6a72-4c33-a2af-0bc943602bc22025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 62559-992
ndc (product): 62559-990
ndc (product): 62559-991
ndc (product): 62559-993
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.d9e772e9-d916-42ae-8020-89b2632361022025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEBryant Ranch Prepackc94b8ecf-249f-42d6-a030-4cfb83fddb082024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 63629-9134
FluconazoleFLUCONAZOLEBryant Ranch Prepack877aea10-b019-4eeb-8a1e-e6ac583df9662024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 63629-9091
FluconazoleFLUCONAZOLEBryant Ranch Prepackb94ca865-ab2f-466c-9913-dde9376e45332024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
ndc (product): 63629-8970
FluconazoleFLUCONAZOLEBryant Ranch Prepack6b2bc10f-21a8-422a-9ea3-ed7788ffce6b2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078423
application number: ANDA078423

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 134 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3194FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3196FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3899FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-3899FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
51407-299FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-299FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-300FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-300FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-301FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-301FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-302FluconazoleFluconazoleGolden State Medical SupplyANDACurrent
51407-302FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-424FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-425FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-426FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
51407-427FluconazoleFluconazoleGolden State Medical Supply, Inc.ANDACurrent
53002-1198FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-1198FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-4400FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-4400FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
55700-490FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA QuaANDACurrent
55700-521FluconazoleFluconazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-990FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-991FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-992FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
62559-993FluconazoleFluconazoleANI Pharmaceuticals, Inc.ANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1947FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1948FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1949FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-1950FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-7986FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-7986FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8970FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8970FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8971FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8971FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9091FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9091FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9134FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-9134FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent
67405-601FluconazoleFluconazoleHarris Pharmaceutical, Inc.ANDACurrent