Application 076617
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No |
| 002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | ||
| A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076617-001 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076617-002 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | c89c3bbd-1170-4170-e053-2a95a90a8e41 | 2026-07-29 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d | 2026-07-23 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Preferred Pharmaceuticals Inc. | 16b6fba0-b96f-4252-a70d-31dc61400298 | 2026-07-22 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Redpharm Drug | 568d9f2f-3394-b972-e063-6394a90a8628 | 2026-07-14 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | 6bb386b0-9dbe-40ee-b873-5215b1905920 | 2026-07-14 | Warnings, Adverse reactions | FLUCONAZOLE |
| FLUCONAZOLE | FLUCONAZOLE | HAWAII REPACK, INC. | 8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8 | 2026-07-03 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | St. Mary's Medical Park Pharmacy | 126406ae-1fdc-df20-e063-6294a90a2718 | 2026-06-29 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 67af604c-928f-468b-ba27-ad45e95d3e7e | 2026-06-24 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | 7259671f-a703-4a2a-81db-9a4839b34072 | 2026-06-24 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | a995790a-8470-4c51-801a-69347151a6fe | 2026-06-24 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Northwind Health Company, LLC | 0de7211d-b8ce-214d-e063-6294a90aec41 | 2026-06-22 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 726daf35-4c03-464f-a814-cc0a715d6031 | 2026-06-12 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | PD-Rx Pharmaceuticals, Inc. | dd975843-c3e4-44f4-bb0d-33b294c1f6fb | 2026-06-12 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 91adb548-9875-47e9-8054-578ed8c7572e | 2026-06-10 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | ASCLEMED USA INC. | 2099c3a0-1911-4d4a-878a-36cf054bdd0b | 2026-05-20 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Bryant Ranch Prepack | e222031d-58f6-46d6-99f8-320b9aacf2b2 | 2026-05-18 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Coupler LLC | 519e44f4-9318-572e-e063-6394a90afe93 | 2026-05-12 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | REMEDYREPACK INC. | 2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f5 | 2026-05-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Cardinal Health 107, LLC | f1bfba3a-5b18-41c0-9084-b1f26bb93ef2 | 2026-04-27 | Warnings, Adverse reactions | FLUCONAZOLE |