Application 077731
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 50MG | No | No |
| 002 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 100MG | No | No |
| 003 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 150MG | No | No |
| 004 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077731-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | |
| A077731-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077731-001 | AB |
| A077731-002 | AB |
| A077731-003 | AB |
| A077731-004 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2008-10-07 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077731-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077731-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077731-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077731-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077731-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077731-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077731-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077731-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077731-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077731-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077731-004 | AB | 1 | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluconazole | FLUCONAZOLE | Redpharm Drug | 568d9f2f-3394-b972-e063-6394a90a8628 | 2026-07-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 6bb386b0-9dbe-40ee-b873-5215b1905920 | 2026-07-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | 126406ae-1fdc-df20-e063-6294a90a2718 | 2026-06-29 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a995790a-8470-4c51-801a-69347151a6fe | 2026-06-24 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 726daf35-4c03-464f-a814-cc0a715d6031 | 2026-06-12 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | ASCLEMED USA INC. | 2099c3a0-1911-4d4a-878a-36cf054bdd0b | 2026-05-20 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | eeeb82e1-d668-418e-9716-f8bcf72f80c0 | 2026-04-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 5cbd78cd-2cd7-4882-9902-bdb7812fbc6b | 2026-04-16 | Warnings, Adverse reactions | 077731 ANDA077731 68788-7293 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | f25f31a6-4bad-40fa-bced-695552e27afd | 2026-02-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 60f3e8af-d98f-48dd-83e6-a78315aaed22 | 2026-02-15 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 98ac5455-d26c-4780-a5a3-bf8d85917626 | 2026-02-09 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | AvPAK | 551a5c8f-57eb-2643-12c6-7c700584b49f | 2026-01-06 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Northwind Health Company, LLC | c924c51c-ed7e-7e72-e053-2995a90adcd3 | 2026-01-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 124c1ffa-08fd-eca5-e063-6294a90af0e2 | 2025-12-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | c6be26bb-af92-405b-9908-972d6e985cf0 | 2025-12-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 01df20c4-7b94-044e-e063-6394a90a406a | 2025-11-17 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 28d53f27-a0cd-4d8d-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 1c82929f-934b-4df4-b24f-1e5da090fd8a | 2025-10-02 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2bd1c038-ab82-496c-8129-3182238ad1a1 | 2025-09-30 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fef2222c-5d61-435e-8761-d8f3d435d6d8 | 2025-09-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-005 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-006 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 63187-584 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 63187-584 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-058 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-059 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-060 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-061 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 68084-728 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-728 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-728 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-728 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-735 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-735 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-735 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68084-735 | Fluconazole | Fluconazole | American Health Packaging | ANDA | Current |
| 68788-7060 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7060 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7293 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7293 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7293 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7293 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7293 | Fluconazole | Fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9245 | Fluconazole | Fluconazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0560 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-3111 | Fluconazole | Fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-783 | Fluconazole | Fluconazole | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-783 | Fluconazole | Fluconazole | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-563 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-563 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-563 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-563 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 71335-1268 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1268 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1268 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 76413-161 | Fluconazole | Fluconazole | Central Texas Community Health Centers | ANDA | Current |