Application 076304
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No |
| 002 | FLUCONAZOLE IN DEXTROSE 5% 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 |
|---|---|---|---|---|---|---|---|
| A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | ||
| A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% 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 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | 2004-07-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076304-001 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML (2MG/ML) | INJECTABLE / INJECTION | AP | RS | 2004-07-29 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076304-002 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML (2MG/ML) | INJECTABLE / INJECTION | AP | RS | 2004-07-29 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076304-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076304-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076304-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076304-002 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076304-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076304-002 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076304-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076304-002 | AP | 1 | ea99ee380514… |
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 | Rising Pharma Holdings, Inc. | 2ca7efcd-4a8d-4139-a3eb-930afd18b13f | 2024-07-04 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Hikma Pharmaceuticals USA Inc. | d3ca59bd-ae00-48ab-89aa-87c7f56e9989 | 2024-06-28 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Baxter Healthcare Company | cd24a261-9c15-42b4-8040-89d2dbda174e | 2024-06-24 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | NuCare Pharmaceuticals,Inc. | 715c53f0-2aea-1f24-e053-2995a90ad463 | 2024-06-10 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Pharmasource Meds, LLC | fe0cc56d-c0b6-f859-e053-6294a90ad932 | 2024-05-28 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Zydus Lifesciences Limited | 0adb2f88-8a6f-4f33-9e2d-73f537e05313 | 2024-03-04 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Direct Rx | 69f199fa-bb92-4837-8b12-427a1c71f622 | 2024-01-09 | Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | A-S Medication Solutions | 2fcac0e4-4f12-42d2-b129-106b4e100075 | 2023-12-03 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f | 2023-10-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| FLUCONAZOLE | FLUCONAZOLE | Asclemed USA, Inc. | 3208dc64-6117-4b2d-9008-76a819cef7d7 | 2023-09-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581 | 2023-04-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | A-S Medication Solutions | 08a54805-4fdf-48fd-bc3e-e9fa38f3c691 | 2023-02-06 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | b0aa9b22-5aef-459f-bb11-b193343eeb86 | 2023-02-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | 88d9904c-0c21-4188-95e2-6479bdf359df | 2023-01-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Proficient Rx LP | fbb1bda3-f733-4404-9c9d-46c418700c03 | 2022-08-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| Fluconazole | FLUCONAZOLE | Asclemed USA, Inc. | 56a9de97-bbb9-4210-9ace-f77317d5f33b | 2022-03-04 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | f232600e-70ce-4001-b9da-31442f0920b9 | 2020-03-01 | Warnings, Adverse reactions | FLUCONAZOLE |
| fluconazole | FLUCONAZOLE | Proficient Rx LP | 7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3 | 2019-10-01 | Warnings, Adverse reactions | FLUCONAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.