Application 078577
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078577-001 | LEVOFLOXACIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | ||
| A078577-002 | LEVOFLOXACIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 |
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 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Levofloxacin | LEVOFLOXACIN | Lupin Pharmaceuticals, Inc. | 4be13bd5-0c39-43c3-9232-b1226ccd4dbc | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 631523e7-7d67-0cc3-e053-2a91aa0abb62 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Gland Pharma Limited | 95479f18-76dc-41cf-a359-922febeed0f2 | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Dr. Reddy's Laboratories Limited | 9b59428a-a23a-b2d9-982f-98f8a1ed381f | 2024-06-29 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Viona Pharmaceuticals Inc | 0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Aurobindo Pharma Limited | 529ac72c-c4a0-4001-8cf9-b94f5bf7265c | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN IN 5% DEXTROSE | Eugia US LLC | 7d3f83bf-2db7-4657-9538-406adf321ad5 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Levofloxacin |
| Levofloxacin | LEVOFLOXACIN | ANI Pharmaceuticals, Inc. | a894e40b-77e4-439b-b0f8-9a5cc7a1dd90 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Eugia US LLC | 4d400bf9-988f-42ec-93f1-e71a93a324b2 | 2024-06-17 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 72cb9372-e9f8-3ca1-e053-2a91aa0ad820 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LLEVOFLOXACIN | Advanced Rx Pharmacy of Tennessee, LLC | 19afbe98-484c-c980-e063-6294a90acdc6 | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | Levofloxacin |
| Levofloxacin | LEVOFLOXACIN | Fresenius Kabi USA, LLC | eb30fafa-bbb9-458f-89df-ae610fa6aa96 | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Asclemed USA, Inc. | 2e32a8aa-047b-46c6-b67b-d88a9a0a810b | 2024-05-13 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Macleods Pharmaceuticals Limited | fc165a6d-24b0-4753-a7ac-94a134dca0d3 | 2023-01-06 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 95149cfb-1a71-42b7-b50d-9a2e94334339 | 2022-09-01 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 30958610-3803-45e6-aa3c-d256decbe6e4 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Hikma Pharmaceuticals USA Inc. | e680c759-16c5-4532-9c9c-f42c8c3df74a | 2019-03-28 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Hikma Pharmaceuticals USA Inc. | f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5 | 2019-03-27 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Baxter Healthcare Corporation | 70c87464-1806-480a-8ebd-3f02987ff436 | 2019-03-22 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9167 | ORIG | 2015-08-13 |