Application 019858
- Type
- NDA
- Sponsor
- BAYER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIPROFLOXACIN | INJECTABLE;INJECTION | 200MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 |
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 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019858-001 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1990-12-26 | cb3db0bc1861… |
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. | 7d533171-0879-3854-e053-2a91aa0a3b46 | 2024-06-12 | Warnings, Adverse reactions | CIPROFLOXACIN |
| 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 |