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 | American Health Packaging | d7aacee3-9d9c-4b36-b735-39bcb9edf941 | 2025-07-23 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 90538767-c84b-4637-8ab6-8c147315eafa | 2025-06-10 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | fd7ea788-29b7-1f0b-e053-6394a90a2980 | 2025-02-04 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 0aacafca-baf8-9a22-e063-6394a90a2ca9 | 2025-02-03 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Direct_Rx | 06f8f4b9-5289-2d59-e063-6294a90a7209 | 2025-01-22 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 068623f9-0f87-50bc-e063-6294a90aea00 | 2025-01-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals, Inc. | 2b9b08b6-7239-473b-e063-6294a90ab7c4 | 2025-01-13 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | 177322f4-9526-40cb-9e5d-bc24e8fb02db | 2024-11-18 | Warnings, Adverse reactions | 077731 ANDA077731 50090-2195 |
| Fluconazole | FLUCONAZOLE | Aurobindo Pharma Limited | 6ebf24fd-41cd-4b3c-8176-a1436253ba2d | 2024-11-14 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | 4eaf5b04-c026-4a49-879f-2925b375f903 | 2024-11-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 3f743514-615e-4e78-8321-24c545a7752f | 2024-09-06 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | NorthStar Rx LLC | d2acccda-8068-46c1-8562-950d7f70ee06 | 2024-07-04 | Warnings, Adverse reactions | 077731 ANDA077731 16714-693 16714-692 16714-694 16714-691 |
| Fluconazole | FLUCONAZOLE | Rising Pharma Holdings, Inc. | 2ca7efcd-4a8d-4139-a3eb-930afd18b13f | 2024-07-04 | Warnings, Adverse reactions | 077731 ANDA077731 57237-003 57237-004 |
| Fluconazole | FLUCONAZOLE | Pharmasource Meds, LLC | fe0cc56d-c0b6-f859-e053-6294a90ad932 | 2024-05-28 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f | 2023-10-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | 88d9904c-0c21-4188-95e2-6479bdf359df | 2023-01-01 | Warnings, Adverse reactions | 077731 ANDA077731 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 12634-780 | Fluconazole | Fluconazole | Apotheca Inc. | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-691 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-692 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-693 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-694 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-642 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-645 | Fluconazole | Fluconazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2195 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-2195 | Fluconazole | Fluconazole | A-S Medication Solutions | ANDA | Current |
| 50268-337 | Fluconazole | Fluconazole | AvPAK | ANDA | Current |
| 50268-337 | Fluconazole | Fluconazole | AvPAK | ANDA | Current |
| 50268-339 | Fluconazole | Fluconazole | AvPAK | ANDA | Current |
| 50268-339 | Fluconazole | Fluconazole | AvPAK | ANDA | Current |
| 51655-435 | Fluconazole | Fluconazole | Northwind Pharmaceuticals | ANDA | Current |
| 52343-085 | Fluconazole | Fluconazole | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-086 | Fluconazole | Fluconazole | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-087 | Fluconazole | Fluconazole | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-088 | Fluconazole | Fluconazole | ACETRIS HEALTH, LLC | ANDA | Current |
| 53002-2198 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2198 | Fluconazole | Fluconazole | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-7138 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7138 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7138 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7138 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 55154-7138 | Fluconazole | Fluconazole | Cardinal Health | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-003 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-004 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |