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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078577-001 | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078577-002 | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) | INJECTABLE / INJECTION | 2015-08-12 | 782e0a99824c… |
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 | Preferred Pharmaceuticals Inc | 067e260c-dc47-4957-a9ff-5a79f17b4ca0 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | DirectRx | dabedb15-5b55-3853-e053-2995a90aa44e | 2025-01-21 | Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | d98cf024-51fa-45a1-b247-da55aba88ca0 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 8423b021-e09c-4f1c-e053-2991aa0afef6 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af4b7333-4f77-4ec9-e053-2a95a90a16d2 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | afd5cb35-4232-f8b1-e053-2a95a90a8c5b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | b001d60e-b8fb-54ff-e053-2a95a90a2970 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | WG Critical Care, LLC | 9020cdeb-65fe-458f-bbbd-69265a49906e | 2024-09-30 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | A-S Medication Solutions | bdc8b2cc-a914-4613-ac7c-e8dfe91dea13 | 2024-09-29 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Golden State Medical Supply, Inc. | bfe280be-0789-69fa-e053-2a95a90a0e13 | 2024-09-16 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 171ab6c6-8eb5-4716-926f-cee52b7d0968 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| LEVOFLOXACIN | LEVOFLOXACIN | Gland Pharma Limited | ba69722b-d7f2-4519-8a63-9ee91294c499 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 54a02488-586d-4c4e-8a35-68a067bdd6e3 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | b7a614b0-f604-48e1-9919-21da8f939d93 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 804ec547-5b89-4fd0-89b3-7445543e563e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Zydus Lifesciences Limited | ffa121b8-388f-4d7b-af48-d4aa8d9b5961 | 2024-08-16 | levofloxacin LEVOFLOXACIN | |
| Levofloxacin | LEVOFLOXACIN | Camber Pharmaceuticals, Inc. | b43e9b51-568c-4d84-bbd1-d237120056c4 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals, Inc. | 4a405103-41e8-6a1f-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | Levofloxacin LEVOFLOXACIN |
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9167 | ORIG | 2015-08-13 |