Application 216164
- Type
- ANDA
- Sponsor
- KNACK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | No | No |
| 002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | No | No |
| 003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | ||
| A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | ||
| A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 |
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 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216164-002 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216164-003 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE / INJECTION | 2024-01-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216164-001 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE / INJECTION | AP | 2024-01-29 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216164-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216164-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216164-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216164-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216164-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216164-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216164-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216164-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216164-003 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216164-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216164-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216164-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216164-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A216164-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A216164-003 | AP | 1 | 1c564ffb4f44… |
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 | REMEDYREPACK INC. | b8ac5047-5203-42c4-886b-dd0b08a1786f | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 16d51c1c-4144-4be7-9356-98fcee621ecd | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Northwind Health Company, LLC | f2f090c2-3ee1-7689-e053-2995a90abe38 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Northwind Health Company, LLC | f780bb91-483a-d1a6-e053-6294a90ab74b | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Northwind Health Company, LLC | f33140d5-59ad-3379-e053-2995a90ae286 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | BPI LABS LLC | b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10 | 2025-12-26 | Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 301ecffc-ecaf-01de-e063-6294a90a61b3 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | ST. MARY'S MEDICAL PARK PHARMACY | 46a3c619-b2a3-3f28-e063-6394a90a2309 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | c6027cde-b9fe-e593-e053-2995a90ac2c1 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Hospira, Inc | 5a1534af-aa1c-4f1d-ba9f-9415b14e1af2 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | VERITYRX, LLC | 427a2077-5dbb-3c5e-e063-6294a90a0839 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 814450ae-439e-4a5d-8c60-9b21b6f14be5 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | b1a4aabb-42af-4133-8e82-0c7ec8fa79c3 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | b8defac4-9deb-433b-928e-0ef4ee0123a2 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | cbd5153f-fada-4682-b858-dc3b6e3173cc | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Lannett Company, Inc. | 362fb864-3afb-4841-a7c4-b64b1346aba0 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | A-S Medication Solutions | 1538ec66-f385-401e-8cfb-d794691e7176 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 64141d0d-0347-470f-a427-9925a2eb357e | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Redpharm Drug | 0a0fd993-7bea-42d8-e063-6394a90a4e0e | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| LEVOFLOXACIN | LEVOFLOXACIN | Advagen Pharma Limited | f2eb9444-333d-4b05-8cf3-2e6690a2bf99 | 2025-03-10 | Warnings, Adverse reactions | LEVOFLOXACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.