Application 207986
- Type
- NDA
- Sponsor
- OTONOMY INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OTIPRIO | CIPROFLOXACIN | INJECTABLE, SUSPENSION;OTIC | 6% (60MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207986-001 | OTIPRIO | CIPROFLOXACIN | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | |
| N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | |
| N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 |
| N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | |
| N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | |
| N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | |
| N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | |
| N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 |
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 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD | 2015-12-10 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N207986-001 | OTIPRIO | 6% (60MG/ML) | INJECTABLE, SUSPENSION / OTIC | RLD, RS | 2015-12-10 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 11369566 | 2029-04-21 | Drug product | 2022-07-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 9205048 | 2029-04-21 | U-1793 | 2016-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 9603796 | 2029-04-21 | U-2252 | Drug substance, Drug product | 2018-03-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 9233068 | 2029-12-11 | Drug product | 2016-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 8318817 | 2030-04-27 | U-1792 | 2016-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 9220796 | 2035-07-01 | Drug product | 2016-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 11040004 | 2037-11-12 | U-2252 | 2021-07-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207986-001 | 11246863 | 2038-11-27 | Drug product | 2022-03-11 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N207986-001 | I-770 | 2021-03-02 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N207986-001 | I-770 | 2021-03-02 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N207986-001 | I-770 | 2021-03-02 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N207986-001 | I-770 | 2021-03-02 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N207986-001 | I-770 | 2021-03-02 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N207986-001 | I-770 | 2021-03-02 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N207986-001 | I-770 | 2021-03-02 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N207986-001 | I-770 | 2021-03-02 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N207986-001 | I-770 | 2021-03-02 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | 641729a3-6dd3-3a2f-e053-2991aa0a015e | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | 5bab9397-b9f3-d309-e053-2991aa0a6612 | 2024-06-04 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Leading Pharma, LLC | 545527e7-05c7-4dbf-ab32-b3fa463d55b0 | 2024-05-10 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | 4f600112-168a-4a58-9914-7c01f71894da | 2024-05-02 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | a57066d7-dc2c-d2d0-b003-d9143fcca1c5 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | A-S Medication Solutions | 6971a958-08f0-4712-bf5f-47fe4f76b863 | 2023-11-13 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Asclemed USA, Inc. | 86c2ba30-9372-4e70-88a2-e6e1da07fa92 | 2023-09-02 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Proficient Rx LP | 6b5fe0aa-c74f-42f3-a84a-1cb16009aa80 | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | PharmPak, Inc. | e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | PharmPak, Inc. | 6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Sagent Pharmaceuticals | 7049f870-6741-4a67-8033-398c36126a06 | 2022-09-19 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Proficient Rx LP | fbcd32c0-bcfd-4cc7-8e81-6612bc0cfc45 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Proficient Rx LP | 05b2836d-cd3d-4d7f-970c-66ec2d788667 | 2022-05-02 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Asclemed USA, Inc. | 1bb1d26e-fad0-4338-8948-3f095d5817a6 | 2022-03-08 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Proficient Rx LP | 4af3894a-8945-4b2d-bdf6-a83bbd415b89 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Aphena Pharma Solutions - Tennessee, LLC | c7bc0d20-526c-48ea-b23a-cea9eb7080ff | 2018-07-09 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0268-8200 | OTIPRIO | OTIPRIO | ALK-Abello, Inc. | NDA | Current |
| 0268-8200 | OTIPRIO | OTIPRIO | ALK-Abello, Inc. | NDA | Current |
| 69251-201 | Otiprio | ciprofloxacin | Otonomy, Inc. | NDA | Current |
| 69251-201 | Otiprio | ciprofloxacin | Otonomy, Inc. | NDA | Current |
| 69251-201 | Otiprio | ciprofloxacin | Otonomy, Inc. | NDA | Current |
| 69251-201 | Otiprio | ciprofloxacin | Otonomy, Inc. | NDA | Current |
| 69251-201 | Otiprio | ciprofloxacin | Otonomy, Inc. | NDA | Current |