Application 076220
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 200MG | No | No |
| 002 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 300MG | No | No |
| 003 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076220-001 | OFLOXACIN | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | ||
| A076220-002 | OFLOXACIN | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | ||
| A076220-003 | OFLOXACIN | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076220-002 | OFLOXACIN | 300MG | TABLET / ORAL | 2003-09-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076220-003 | OFLOXACIN | 400MG | TABLET / ORAL | 2003-09-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076220-001 | OFLOXACIN | 200MG | TABLET / ORAL | 2003-09-02 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| ofloxacin | OFLOXACIN OTIC | REMEDYREPACK INC. | 50bca624-4dc0-4d1b-a693-2eb602eaf2f2 | 2026-08-14 | Warnings, Adverse reactions | ofloxacin |
| Ofloxacin | OFLOXACIN | REMEDYREPACK INC. | 38d0bbce-58ca-4fc1-a887-87b61fef9a87 | 2026-08-14 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | NorthStar RxLLC | b95114f6-6753-4217-b621-44fa34afc298 | 2026-08-13 | Warnings, Adverse reactions | ofloxacin |
| ofloxacin | OFLOXACIN OTIC | Lifestar Pharma LLC | 0621700e-6315-47ff-a8ed-cccf7d6fc56a | 2026-08-13 | Warnings, Adverse reactions | ofloxacin |
| Ofloxacin | OFLOXACIN | Preferred Pharmaceuticals, Inc. | 0c01de7a-a885-4bf0-8df0-7c62170b7850 | 2026-08-06 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN | Preferred Pharmaceuticals Inc. | 306ed758-3c43-4f42-bd44-562ec65891dc | 2026-08-06 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | Sportpharm LLC | 3f5972db-4eaf-4237-944d-8f63eff7b9b1 | 2026-06-26 | Warnings, Adverse reactions | ofloxacin |
| Ofloxacin | OFLOXACIN | St. Mary's Medical Park Pharmacy | 2d55b26d-9d12-ca29-e063-6294a90ab237 | 2026-06-25 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| OFLOXACIN | OFLOXACIN | Modavar Pharmaceuticals LLC | 93ed9f70-b44f-496b-bdfc-c1bd5f1c260b | 2026-06-06 | Boxed warning, Warnings, Adverse reactions | OFLOXACIN OFLOXACIN |
| Ofloxacin | OFLOXACIN | ST. MARY'S MEDICAL PARK PHARMACY | 27c247e5-ef93-e9a5-e063-6394a90a2e1e | 2026-06-03 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN | REMEDYREPACK INC. | d97651cc-d9ea-4be4-8ea1-3d0278582dd5 | 2026-04-15 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
| OFLOXACIN OTIC | OFLOXACIN | DIRECT RX | a7952956-b64a-0f99-e053-2995a90a0f91 | 2026-03-17 | Warnings, Adverse reactions | OFLOXACIN |
| Ofloxacin | OFLOXACIN | Preferred Pharmaceuticals Inc. | 5f4213e4-de32-4c03-8800-e254b98538ea | 2026-03-17 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | A-S Medication Solutions | 537c6351-c7f1-47c9-95de-011bac850768 | 2026-01-23 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | Preferred Pharmaceuticals Inc. | f7916bb3-7593-45f8-b9de-98e0f2d57227 | 2026-01-19 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | Rising Pharma Holdings, Inc. | 2e912ed6-51e8-40c3-bf10-2af092c63be8 | 2026-01-02 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | Redpharm Drug | 2fbd51a5-462c-4741-e063-6394a90a0d87 | 2025-12-30 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| OFLOXACIN | OFLOXACIN | Redpharm Drug | 37456656-77c8-d74c-e063-6294a90ab729 | 2025-12-13 | Warnings, Adverse reactions | OFLOXACIN OFLOXACIN |
| Ofloxacin | OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3% | SOLA Pharmaceuticals, LLC | 4ca27244-ed70-4868-b2d8-8f97c3a52148 | 2025-12-08 | Warnings, Adverse reactions | Ofloxacin |
| Ofloxacin | OFLOXACIN | Redpharm Drug | 3dd035d0-c3ec-3fc2-e063-6294a90a4aac | 2025-12-02 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |