Application 078423
- Type
- ANDA
- Sponsor
- HARRIS PHARM
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 |
|---|---|---|---|---|---|---|---|
| A078423-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | |
| A078423-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078423-001 | AB |
| A078423-002 | AB |
| A078423-003 | AB |
| A078423-004 | 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 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2011-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2011-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2011-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2011-03-07 | 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 | A078423-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078423-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078423-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078423-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078423-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078423-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078423-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078423-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078423-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078423-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078423-004 | 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 | REMEDYREPACK INC. | 91adb548-9875-47e9-8054-578ed8c7572e | 2026-06-10 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Golden State Medical Supply, Inc. | c2c7242d-d172-4733-e053-2995a90acb2e | 2026-02-10 | Warnings, Adverse reactions | 078423 ANDA078423 51407-426 51407-427 51407-425 51407-424 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 2c9abaee-461f-437d-adda-e96d7ae3dd01 | 2026-01-23 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a0f1c111-e11e-4b7e-b990-8bc271cbc940 | 2026-01-14 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 701cd91f-4f79-48a7-8fe5-a9678d7a4ac8 | 2025-10-06 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | ANI Pharmaceuticals, Inc. | 8f90f169-6a72-4c33-a2af-0bc943602bc2 | 2025-08-08 | Warnings, Adverse reactions | 078423 ANDA078423 62559-992 62559-990 62559-991 62559-993 |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | d9e772e9-d916-42ae-8020-89b263236102 | 2025-04-17 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | c94b8ecf-249f-42d6-a030-4cfb83fddb08 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 63629-9134 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 877aea10-b019-4eeb-8a1e-e6ac583df966 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 63629-9091 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | b94ca865-ab2f-466c-9913-dde9376e4533 | 2024-10-08 | Warnings, Adverse reactions | 078423 ANDA078423 63629-8970 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 6b2bc10f-21a8-422a-9ea3-ed7788ffce6b | 2024-10-07 | Warnings, Adverse reactions | 078423 ANDA078423 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | b0aa9b22-5aef-459f-bb11-b193343eeb86 | 2023-02-01 | Warnings, Adverse reactions | 078423 ANDA078423 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-3194 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3194 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3194 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3196 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3196 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3196 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3899 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-3899 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 51407-299 | Fluconazole | Fluconazole | Golden State Medical Supply | ANDA | Current |
| 51407-299 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-300 | Fluconazole | Fluconazole | Golden State Medical Supply | ANDA | Current |
| 51407-300 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-301 | Fluconazole | Fluconazole | Golden State Medical Supply | ANDA | Current |
| 51407-301 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-302 | Fluconazole | Fluconazole | Golden State Medical Supply | ANDA | Current |
| 51407-302 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-424 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-424 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-424 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-424 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-425 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-425 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-425 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-425 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-426 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-426 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-426 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-426 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-426 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-427 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-427 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-427 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-427 | Fluconazole | Fluconazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 53002-1198 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1198 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4400 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4400 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-490 | Fluconazole | Fluconazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-521 | Fluconazole | Fluconazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-521 | Fluconazole | Fluconazole | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-521 | Fluconazole | Fluconazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 62559-990 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-990 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-990 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-991 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-991 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-991 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-992 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-992 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-992 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-993 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-993 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-993 | Fluconazole | Fluconazole | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 63629-1947 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1947 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1947 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1948 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1948 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1948 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1948 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1949 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1949 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1949 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1950 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1950 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-1950 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-7986 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-7986 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8970 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8970 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8971 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8971 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9091 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9091 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9134 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-9134 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 67405-601 | Fluconazole | Fluconazole | Harris Pharmaceutical, Inc. | ANDA | Current |
| 67405-601 | Fluconazole | Fluconazole | Harris Pharmaceutical, Inc. | ANDA | Current |
| 67405-601 | Fluconazole | Fluconazole | Harris Pharmaceutical, Inc. | ANDA | Current |
| 67405-601 | Fluconazole | Fluconazole | Harris Pharmaceutical, Inc. | ANDA | Current |