Application 202801
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 250MG | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 500MG | No | No |
| 003 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 750MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202801-001 | LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | |
| A202801-002 | LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | |
| A202801-003 | LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202801-001 | AB |
| A202801-002 | AB |
| A202801-003 | AB |
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 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2015-01-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2015-01-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202801-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2015-01-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202801-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202801-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202801-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202801-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202801-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202801-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202801-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202801-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202801-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202801-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202801-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202801-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202801-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202801-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202801-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202801-001 | AB | 1 | 8072bd15b7f6… |
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. | 2a4e97e0-0709-411b-92e8-6f7d669412e4 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 70518-0968 |
| Levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals, Inc. | bcad1dad-53aa-43dd-90f3-cc17cc9598d5 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 68788-6938 |
| Levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals, Inc. | 2a8676a9-247f-4fdb-b644-e9785d98771f | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | 4f40d5fa-ebcc-516c-e054-00144ff8d46c | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 61919-426 |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | b8ac5047-5203-42c4-886b-dd0b08a1786f | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 70518-0719 |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 16d51c1c-4144-4be7-9356-98fcee621ecd | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 70518-0587 |
| Levofloxacin | LEVOFLOXACIN | ST. MARY'S MEDICAL PARK PHARMACY | 46a3c619-b2a3-3f28-e063-6394a90a2309 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | c6027cde-b9fe-e593-e053-2995a90ac2c1 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 68071-2074 |
| Levofloxacin | LEVOFLOXACIN | VERITYRX, LLC | 427a2077-5dbb-3c5e-e063-6294a90a0839 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | A-S Medication Solutions | 1538ec66-f385-401e-8cfb-d794691e7176 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 50090-3311 50090-3214 |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 64141d0d-0347-470f-a427-9925a2eb357e | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 05d179f5-b200-8597-e063-6394a90a10cc | 2025-03-04 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 80501b71-2f08-2ef5-e053-2991aa0a6e86 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 68071-4738 |
| Levofloxacin | LEVOFLOXACIN | DirectRx | dabedb15-5b55-3853-e053-2995a90aa44e | 2025-01-21 | Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | d98cf024-51fa-45a1-b247-da55aba88ca0 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 8423b021-e09c-4f1c-e053-2991aa0afef6 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 68071-1860 |
| Levofloxacin | LEVOFLOXACIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af4b7333-4f77-4ec9-e053-2a95a90a16d2 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | b001d60e-b8fb-54ff-e053-2a95a90a2970 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
| Levofloxacin | LEVOFLOXACIN | A-S Medication Solutions | bdc8b2cc-a914-4613-ac7c-e8dfe91dea13 | 2024-09-29 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 50090-3314 |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 171ab6c6-8eb5-4716-926f-cee52b7d0968 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 202801 ANDA202801 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-721 | Levofloxacin | Levofloxacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-722 | Levofloxacin | Levofloxacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-723 | Levofloxacin | Levofloxacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3214 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3214 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3214 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3311 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3314 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3314 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 53002-1350 | Levofloxacin | Levofloxacin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1350 | Levofloxacin | Levofloxacin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 61919-426 | LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | ANDA | Current |
| 61919-426 | LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | ANDA | Current |
| 61919-426 | LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-833 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 67296-1393 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1393 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1393 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1400 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1400 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1400 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1641 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1641 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1860 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1860 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2074 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3093 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3093 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3093 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3166 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3166 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3218 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-3218 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3218 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4512 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4512 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4512 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4512 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4512 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4547 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4738 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4738 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4738 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6938 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6938 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6938 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6938 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6938 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7037 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7037 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0587 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0719 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0968 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70934-050 | Levofloxacin | Levofloxacin | Denton Pharma, Inc. | ANDA | Current |
| 70934-050 | Levofloxacin | Levofloxacin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-050 | Levofloxacin | Levofloxacin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10111 | ORIG | 2015-01-12 |