Application 076077
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA 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 |
|---|---|---|---|---|---|---|---|
| A076077-001 | FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | ||
| A076077-002 | FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | ||
| A076077-003 | FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | ||
| A076077-004 | FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076077-001 | FLUCONAZOLE | 50MG | TABLET / ORAL | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076077-002 | FLUCONAZOLE | 100MG | TABLET / ORAL | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076077-003 | FLUCONAZOLE | 150MG | TABLET / ORAL | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076077-004 | FLUCONAZOLE | 200MG | TABLET / ORAL | 2004-07-29 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076077-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076077-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076077-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076077-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076077-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076077-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076077-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076077-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076077-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076077-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076077-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076077-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076077-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076077-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076077-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076077-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076077-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076077-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076077-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076077-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076077-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076077-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076077-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076077-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076077-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076077-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076077-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076077-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076077-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076077-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076077-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076077-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076077-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076077-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076077-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076077-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076077-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076077-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076077-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076077-004 | AB | 1 | c0c555d07b60… |
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 | Coupler LLC | 519e44f4-9318-572e-e063-6394a90afe93 | 2026-05-12 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f5 | 2026-05-01 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Cardinal Health 107, LLC | f1bfba3a-5b18-41c0-9084-b1f26bb93ef2 | 2026-04-27 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 8a4d6d9e-02ae-42e4-83ec-f5c4e135273b | 2026-04-24 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | eeeb82e1-d668-418e-9716-f8bcf72f80c0 | 2026-04-17 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 5cbd78cd-2cd7-4882-9902-bdb7812fbc6b | 2026-04-16 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Zydus Pharmaceuticals (USA) Inc. | d1364455-1537-46d4-b093-38cca3be778f | 2026-04-07 | Warnings, Adverse reactions | fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Mylan Pharmaceuticals Inc. | 737e0fac-a2d2-4053-a0d7-edbfb6248f69 | 2026-04-02 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Diflucan | FLUCONAZOLE | Roerig | f694c617-3383-416c-91b6-b94fda371204 | 2026-04-02 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Major Pharmaceuticals | 13184b13-e252-4b4d-a3e2-cfc4ad3d55b7 | 2026-03-19 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | f25f31a6-4bad-40fa-bced-695552e27afd | 2026-02-17 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 60f3e8af-d98f-48dd-83e6-a78315aaed22 | 2026-02-15 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Golden State Medical Supply, Inc. | c2c7242d-d172-4733-e053-2995a90acb2e | 2026-02-10 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Sportpharm LLC | 98ac5455-d26c-4780-a5a3-bf8d85917626 | 2026-02-09 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Glenmark Pharmaceuticals Inc., USA | 3da5f41d-5200-45ac-b89d-00881237ec85 | 2026-01-29 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 2c9abaee-461f-437d-adda-e96d7ae3dd01 | 2026-01-23 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a0f1c111-e11e-4b7e-b990-8bc271cbc940 | 2026-01-14 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 1a8bd42a-2bce-4b41-8678-67033e7707dd | 2026-01-13 | Warnings, Adverse reactions | fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Zhejiang Poly Pharm. Co., Ltd. | 2a3ba181-5baa-5942-e063-6294a90a82b2 | 2026-01-07 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | AvPAK | 551a5c8f-57eb-2643-12c6-7c700584b49f | 2026-01-06 | Warnings, Adverse reactions | Fluconazole FLUCONAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, | ANDA | Current |
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5410 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5411 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5412 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-5413 | Fluconazole | Fluconazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 10544-178 | Fluconazole | Fluconazole | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-229 | Fluconazole | Fluconazole | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42852-003 | Fluconazole | Fluconazole | Apothecary Shop Wholesale Inc. | ANDA | Current |
| 61919-282 | FLUCONAZOLE | FLUCONAZOLE | DIRECT RX | ANDA | Current |
| 61919-419 | FLUCONAZOLE | FLUCONAZOLE | DIRECT RX | ANDA | Current |
| 61919-419 | FLUCONAZOLE | FLUCONAZOLE | DIRECT RX | ANDA | Current |
| 63187-613 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 63187-613 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 63629-8749 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-8749 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 66116-481 | Fluconazole | Fluconazole | MedVantx, Inc. | ANDA | Current |
| 66116-510 | Fluconazole | Fluconazole | MedVantx, Inc. | ANDA | Current |
| 66336-570 | Fluconazole | Fluconazole | Dispensing Solutions, Inc. | ANDA | Current |
| 68788-9926 | Fluconazole | Fluconazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9927 | Fluconazole | Fluconazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71205-573 | Fluconazole | Fluconazole | Proficient Rx LP | ANDA | Current |
| 71335-1511 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1511 | Fluconazole | Fluconazole | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31071 | ORIG | 2004-07-30 |