Application 076848
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFLOXACIN | OFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 0.3% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076848-001 | OFLOXACIN | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 |
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 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076848-001 | OFLOXACIN | 0.3% | SOLUTION/DROPS / OPHTHALMIC | 2008-11-25 | f41ea6bd6efb… |
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 | NorthStar RxLLC | 7c98c671-aefa-48c3-971a-001f16aa72a8 | 2024-08-29 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | A-S Medication Solutions | 71949588-42e2-446c-b7ec-904c09b2f95f | 2024-08-07 | Warnings, Adverse reactions | ofloxacin |
| ofloxacin | OFLOXACIN | NuCare Pharmaceuticals,Inc. | ff9776b3-a244-e1ea-e053-6294a90aeb7b | 2024-08-05 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | NuCare Pharmaceuticals,Inc. | 1e917318-cdc7-cd2c-e063-6294a90a0cc2 | 2024-08-02 | Warnings, Adverse reactions | ofloxacin |
| Ofloxacin | OFLOXACIN | Proficient Rx LP | 5a9de529-6f85-467a-97b0-8ce124c31173 | 2024-08-01 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin Otic | OFLOXACIN | A-S Medication Solutions | 9d4b1225-e20d-4ace-850a-506fd031cac7 | 2024-07-18 | Warnings, Adverse reactions | OFLOXACIN |
| Ofloxacin | OFLOXACIN OTIC | Amneal Pharmaceuticals NY LLC | ba37e2a0-1bf7-41ca-bddd-35fcb77f87de | 2024-07-18 | Warnings, Adverse reactions | Ofloxacin |
| Ofloxacin | OFLOXACIN | NuCare Pharmaceuticals,Inc. | af861f20-5ec8-2883-e053-2a95a90a2312 | 2024-07-17 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | NuCare Pharmaceuticals,Inc. | ae6b5cb0-aa18-a6d2-e053-2995a90a525d | 2024-07-17 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin Otic | OFLOXACIN | NuCare Pharmaceuticals,Inc. | 79ef87c3-1f09-1625-e053-2991aa0a84ae | 2024-07-17 | Warnings, Adverse reactions | OFLOXACIN |
| OFLOXACIN | OFLOXACIN | Leading Pharma, LLC | 7552729e-a41e-4eb1-8b37-b48a86112790 | 2024-07-01 | Warnings, Adverse reactions | OFLOXACIN OFLOXACIN |
| OCUFLOX | OFLOXACIN | Allergan, Inc. | 7aab4449-3dda-4e2c-8e40-b3244a548bf5 | 2024-06-13 | Warnings, Adverse reactions | OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | Asclemed USA, Inc. | ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c | 2024-06-12 | Warnings, Adverse reactions | ofloxacin |
| ofloxacin | OFLOXACIN | Proficient Rx LP | 0c4e0b81-a344-4678-97d2-b15dc2857882 | 2024-05-01 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN | A-S Medication Solutions | 392d458f-8815-49f4-9c2b-0e721e295b1f | 2024-04-25 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| OFLOXACIN | OFLOXACIN | Leading Pharma, LLC | e43bf505-1030-49cd-a144-19b997fb5575 | 2024-04-04 | Warnings, Adverse reactions | OFLOXACIN OFLOXACIN |
| ofloxacin | OFLOXACIN OTIC | Proficient Rx LP | 79074efc-83ed-4473-bb86-9f635928ea92 | 2024-03-01 | Warnings, Adverse reactions | ofloxacin |
| Ofloxacin | OFLOXACIN | NuCare Pharmceuticals,Inc. | 102c825b-af5c-42e7-e063-6394a90a81a1 | 2024-01-30 | Warnings, Adverse reactions | Ofloxacin OFLOXACIN |
| Ofloxacin | OFLOXACIN OTIC | A-S Medication Solutions | d89fa470-c98b-433a-829b-abe97eb66419 | 2024-01-21 | Warnings, Adverse reactions | Ofloxacin |
| ofloxacin | OFLOXACIN | A-S Medication Solutions | 48dc8354-9a36-427b-ade9-818db6bfb01b | 2023-11-07 | Warnings, Adverse reactions | ofloxacin OFLOXACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44617 | ORIG | 2008-12-22 |