Application 208963
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A208963-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | |
| A208963-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208963-001 | AB |
| A208963-002 | AB |
| A208963-003 | AB |
| A208963-004 | 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 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | AB | 2017-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | AB | 2017-02-16 | 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 | A208963-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208963-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208963-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208963-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208963-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208963-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208963-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208963-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208963-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208963-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208963-004 | 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 | A-S Medication Solutions | 7961c029-746c-48c3-888b-8f8344102873 | 2026-07-30 | Warnings, Adverse reactions | 208963 ANDA208963 50090-4864 |
| fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d | 2026-07-23 | Warnings, Adverse reactions | 208963 ANDA208963 70518-2415 |
| fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 16b6fba0-b96f-4252-a70d-31dc61400298 | 2026-07-22 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 67af604c-928f-468b-ba27-ad45e95d3e7e | 2026-06-24 | Warnings, Adverse reactions | 208963 ANDA208963 71335-0686 |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 7259671f-a703-4a2a-81db-9a4839b34072 | 2026-06-24 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | Zydus Pharmaceuticals (USA) Inc. | d1364455-1537-46d4-b093-38cca3be778f | 2026-04-07 | Warnings, Adverse reactions | 208963 ANDA208963 70710-1140 70710-1137 70710-1138 70710-1139 |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 1a8bd42a-2bce-4b41-8678-67033e7707dd | 2026-01-13 | Warnings, Adverse reactions | 208963 ANDA208963 50090-4425 |
| FLUCONAZOLE | FLUCONAZOLE | direct rx | b3db505a-9677-6f5a-e053-2a95a90a13d4 | 2025-01-17 | Warnings, Adverse reactions | 208963 ANDA208963 |
| fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 715c53f0-2aea-1f24-e053-2995a90ad463 | 2024-06-10 | Warnings, Adverse reactions | 208963 ANDA208963 68071-4501 |
| fluconazole | FLUCONAZOLE | Zydus Lifesciences Limited | 0adb2f88-8a6f-4f33-9e2d-73f537e05313 | 2024-03-04 | Warnings, Adverse reactions | 208963 ANDA208963 70771-1063 70771-1064 70771-1066 70771-1065 |
| Fluconazole | FLUCONAZOLE | Direct Rx | 69f199fa-bb92-4837-8b12-427a1c71f622 | 2024-01-09 | Adverse reactions | 208963 ANDA208963 61919-493 |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 08a54805-4fdf-48fd-bc3e-e9fa38f3c691 | 2023-02-06 | Warnings, Adverse reactions | 208963 ANDA208963 50090-5299 |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | f232600e-70ce-4001-b9da-31442f0920b9 | 2020-03-01 | Warnings, Adverse reactions | 208963 ANDA208963 71205-283 |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | 7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3 | 2019-10-01 | Warnings, Adverse reactions | 208963 ANDA208963 71205-081 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4425 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-4425 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-4426 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-4864 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-4864 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50090-5299 | fluconazole | fluconazole | A-S Medication Solutions | ANDA | Current |
| 50436-1139 | fluconazole | fluconazole | Unit Dose Services | ANDA | Current |
| 60760-113 | fluconazole | fluconazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-493 | Fluconazole | Fluconazole | Direct Rx | ANDA | Current |
| 61919-493 | Fluconazole | Fluconazole | Direct Rx | ANDA | Current |
| 63629-8054 | fluconazole | fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 68071-2601 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2609 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4386 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4386 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4437 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4501 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4501 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4501 | fluconazole | fluconazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7150 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7150 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7150 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7150 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7150 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7203 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7203 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7888 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7888 | fluconazole | fluconazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2411 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2411 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2411 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2411 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2411 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2415 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2415 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2415 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2415 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2415 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-3100 | fluconazole | fluconazole | REMEDYREPACK INC. | ANDA | Current |
| 70710-1137 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1137 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1137 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1137 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1138 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1138 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1138 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1138 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1139 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1139 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1139 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1139 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1140 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1140 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1140 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1140 | fluconazole | fluconazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1063 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1063 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1063 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1063 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1064 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1064 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1064 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1064 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1065 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1065 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1065 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1065 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1066 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1066 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1066 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70771-1066 | fluconazole | fluconazole | Cadila Healthcare Limited | ANDA | Current |
| 70934-935 | fluconazole | fluconazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-081 | fluconazole | fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-081 | fluconazole | fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-283 | fluconazole | fluconazole | Proficient Rx LP | ANDA | Current |
| 71205-283 | fluconazole | fluconazole | Proficient Rx LP | ANDA | Current |
| 71335-0686 | fluconazole | fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0686 | fluconazole | fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0686 | fluconazole | fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0686 | fluconazole | fluconazole | Bryant Ranch Prepack | ANDA | Current |