Application 077253

Type
ANDA
Sponsor
GLENMARK GENERICS

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
A077253-001FLUCONAZOLEFLUCONAZOLE50MGTABLET / ORALAB2006-01-25
A077253-002FLUCONAZOLEFLUCONAZOLE100MGTABLET / ORALAB2006-01-25
A077253-003FLUCONAZOLEFLUCONAZOLE150MGTABLET / ORALAB2006-01-25
A077253-004FLUCONAZOLEFLUCONAZOLE200MGTABLET / ORALAB2006-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077253-001AB
A077253-002AB
A077253-003AB
A077253-004AB

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 UTC2026-02A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077253-001FLUCONAZOLE50MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-002FLUCONAZOLE100MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-003FLUCONAZOLE150MGTABLET / ORALAB2006-01-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-004FLUCONAZOLE200MGTABLET / ORALAB2006-01-25d06236e962d9…

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 UTC2026-02A077253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077253-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077253-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077253-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077253-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077253-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077253-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077253-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077253-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077253-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077253-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077253-004AB1d06236e962d9…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLESt. Mary's Medical Park Pharmacyc89c3bbd-1170-4170-e053-2a95a90a8e412026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLENorthwind Health Company, LLC0de7211d-b8ce-214d-e063-6294a90aec412026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEPD-Rx Pharmaceuticals, Inc.dd975843-c3e4-44f4-bb0d-33b294c1f6fb2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEBryant Ranch Prepacke222031d-58f6-46d6-99f8-320b9aacf2b22026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLECoupler LLC519e44f4-9318-572e-e063-6394a90afe932026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEGlenmark Pharmaceuticals Inc., USA3da5f41d-5200-45ac-b89d-00881237ec852026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
ndc (product): 68462-119
ndc (product): 68462-101
ndc (product): 68462-103
ndc (product): 68462-104
ndc (product): 68462-102
FluconazoleFLUCONAZOLENorthwind Health Company, LLCf76bf2f7-1752-7656-e053-6394a90a8d222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEBluePoint Laboratories83bcb8fc-53f1-4d7b-b083-0905b52c6c7e2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLERadha Pharmaceuticals Inc4616c7ad-be61-7ac0-e063-6394a90ab9ed2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEREMEDYREPACK INC.aaf9e5f8-048e-407c-bc11-ad4edff85c052025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLECoupler LLC325d5d69-5132-79ea-e063-6294a90afdd02025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPc0193e27-f1a4-4698-a6bb-3df772c162562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.cf6c7cca-d074-2178-e053-2a95a90a3af72025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FLUCONAZOLEFLUCONAZOLEDirect Rxdb886cfe-ea23-50c9-e053-2995a90a4d102025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
ndc (product): 72189-342
FluconazoleFLUCONAZOLEA-S Medication Solutions2fcac0e4-4f12-42d2-b129-106b4e1000752023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEProficient Rx LPfbb1bda3-f733-4404-9c9d-46c418700c032022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
FluconazoleFLUCONAZOLEAsclemed USA, Inc.56a9de97-bbb9-4210-9ace-f77317d5f33b2022-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077253
application number: ANDA077253
ndc (product): 76420-164

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 132 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-102FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-103FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-104FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-119FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-119FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-119FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-119FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-2518FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7621FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7621FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7959FluconazoleFluconazolePreferred Pharmaceuticals Inc., USAANDACurrent
68788-7959FluconazoleFluconazolePreferred Pharmaceuticals Inc., USAANDACurrent
68788-8220FluconazoleFluconazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-9190FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9190FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2087FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-2087FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-2087FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-2087FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-2087FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-3092FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-3092FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
70518-3312FluconazoleFluconazoleREMEDYREPACK INC.ANDACurrent
71335-0557FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-0557FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-0557FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-0557FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-1176FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-1176FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
72189-342FLUCONAZOLEFLUCONAZOLEDirect RxANDACurrent
76420-164FluconazoleFluconazoleAsclemed USA, Inc.ANDACurrent