Application 020635
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVAQUIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | Yes | No |
| 002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | LEVAQUIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | Yes | No |
| 005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020635-001 | LEVAQUIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | |
| N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | |
| N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | |
| N020635-004 | LEVAQUIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | |
| N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 |
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 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020635-001 | LEVAQUIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020635-002 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020635-003 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020635-004 | LEVAQUIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020635-005 | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1996-12-20 | 5bbf6a4d5a75… |
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 | Sagent Pharmaceuticals | 699fbdb8-a6fd-476a-9b80-08197d869534 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | HAWAII REPACK, INC. | 857f256c-88ac-4f73-9815-c2724edf2f1e | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 2a4e97e0-0709-411b-92e8-6f7d669412e4 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 710c0c10-89a5-4954-8f74-acc187c5cf0f | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Chartwell RX, LLC | 5c6c117c-9d91-48f4-9aaa-ee70b99218c2 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | f14cf651-a213-4a4f-adb9-f628562af27c | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 5261da15-1b6c-fbe2-e063-6394a90ad85e | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Cardinal Health 107, LLC | 070375be-3b67-4299-ae8f-4a7b157ac16f | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals, Inc. | bcad1dad-53aa-43dd-90f3-cc17cc9598d5 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals, Inc. | 2a8676a9-247f-4fdb-b644-e9785d98771f | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 9f944b63-9b60-437a-ba57-d14d7976bc32 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | 4f40d5fa-ebcc-516c-e054-00144ff8d46c | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | a5ae33ad-4703-4cb2-8618-6439c906be99 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 44f31105-5fc9-43d4-e063-6294a90a510f | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 264a3f71-f23e-45e3-926a-421bcccf4e3d | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals Inc. | 7a12135e-cbad-4fe1-98f7-53c41d1f2a21 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | LEVOFLOXACIN |
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47162 | SUPPL | 2017-02-10 |
| 47150 | SUPPL | 2017-02-09 |
| 35039 | SUPPL | 2016-07-26 |
| 2959 | SUPPL | 2016-07-26 |
| 41511 | SUPPL | 2015-03-11 |
| 35038 | SUPPL | 2014-05-28 |
| 25402 | SUPPL | 2014-05-28 |
| 2958 | SUPPL | 2013-08-16 |
| 35037 | SUPPL | 2013-08-15 |
| 41512 | SUPPL | 2012-06-22 |
| 20791 | SUPPL | 2012-06-22 |
| 25399 | SUPPL | 2012-05-01 |
| 35035 | SUPPL | 2012-04-30 |
| 25401 | SUPPL | 2011-10-13 |
| 25400 | SUPPL | 2011-10-13 |
| 35036 | SUPPL | 2011-10-12 |
| 12901 | SUPPL | 2011-10-12 |
| 35034 | SUPPL | 2011-06-14 |
| 2957 | SUPPL | 2011-06-14 |
| 35033 | SUPPL | 2011-03-04 |
| 2956 | SUPPL | 2011-03-03 |
| 23172 | ORIG | 2009-11-19 |
| 35032 | SUPPL | 2009-05-11 |
| 25398 | SUPPL | 2009-05-05 |
| 2955 | SUPPL | 2009-03-13 |
| 12900 | SUPPL | 2008-10-08 |
| 25397 | SUPPL | 2008-10-07 |
| 41510 | SUPPL | 2008-08-01 |
| 41509 | SUPPL | 2008-08-01 |
| 24178 | SUPPL | 2008-07-16 |
| 12899 | SUPPL | 2008-06-05 |
| 2952 | SUPPL | 2008-05-08 |
| 25396 | SUPPL | 2008-04-18 |
| 2954 | SUPPL | 2008-01-09 |
| 12898 | SUPPL | 2007-12-14 |
| 35031 | SUPPL | 2007-11-19 |
| 35030 | SUPPL | 2007-11-19 |
| 25395 | SUPPL | 2007-11-19 |
| 2953 | SUPPL | 2007-11-19 |
| 2951 | SUPPL | 2007-09-25 |
| 2950 | SUPPL | 2007-09-25 |
| 35028 | SUPPL | 2007-09-19 |
| 35026 | SUPPL | 2007-09-19 |
| 25394 | SUPPL | 2007-07-05 |
| 35029 | SUPPL | 2007-06-27 |
| 35027 | SUPPL | 2007-06-04 |
| 25392 | SUPPL | 2007-06-04 |
| 25393 | SUPPL | 2007-05-16 |
| 12897 | SUPPL | 2007-05-16 |
| 12896 | SUPPL | 2006-06-28 |
| 2949 | SUPPL | 2006-06-28 |
| 12895 | SUPPL | 2006-01-27 |
| 35025 | SUPPL | 2005-08-08 |
| 25391 | SUPPL | 2005-08-08 |
| 20790 | SUPPL | 2005-06-27 |
| 20789 | SUPPL | 2005-06-27 |
| 20788 | SUPPL | 2005-06-27 |
| 35023 | SUPPL | 2004-12-03 |
| 25390 | SUPPL | 2004-12-02 |
| 35024 | SUPPL | 2004-11-08 |
| 2948 | SUPPL | 2004-11-08 |
| 12894 | SUPPL | 2004-09-15 |
| 12893 | SUPPL | 2004-09-15 |
| 2947 | SUPPL | 2004-09-15 |
| 2946 | SUPPL | 2004-09-15 |
| 41508 | SUPPL | 2004-09-09 |
| 20787 | SUPPL | 2004-09-09 |
| 2945 | SUPPL | 2004-07-21 |
| 35018 | SUPPL | 2004-06-08 |
| 12892 | SUPPL | 2004-04-05 |
| 25389 | SUPPL | 2004-03-10 |
| 2944 | SUPPL | 2003-12-04 |
| 35022 | SUPPL | 2003-06-08 |
| 2943 | SUPPL | 2003-06-08 |
| 2942 | SUPPL | 2002-10-30 |
| 35021 | SUPPL | 2001-12-18 |
| 35020 | SUPPL | 2001-12-18 |
| 35019 | SUPPL | 2001-12-18 |
| 25388 | SUPPL | 2001-12-18 |
| 25387 | SUPPL | 2001-12-18 |
| 25386 | SUPPL | 2001-12-18 |
| 25385 | SUPPL | 2000-09-08 |
| 12891 | SUPPL | 2000-09-08 |
| 25384 | SUPPL | 2000-02-02 |
| 20786 | SUPPL | 1999-07-02 |
| 2941 | SUPPL | 1998-12-17 |
| 20785 | ORIG | 1997-12-11 |
| 66975 | SUPPL | 1900-01-01 |
| 66974 | SUPPL | 1900-01-01 |
| 52016 | SUPPL | 1900-01-01 |
| 52015 | SUPPL | 1900-01-01 |
| 52010 | SUPPL | 1900-01-01 |
| 52007 | SUPPL | 1900-01-01 |
| 52004 | SUPPL | 1900-01-01 |