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 | REMEDYREPACK INC. | c08b37c3-5f01-47ed-9508-02813bbd008b | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Northwind Health Company, LLC | 4deea61e-f3ca-b35d-e063-6294a90a9d41 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | HAWAII REPACK, INC | 4caf49d9-b06f-4d57-aac3-cc64ae12cc95 | 2026-07-12 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | St. Mary's Medical Park Pharmacy | 348e810c-e572-f3d2-e063-6394a90a0855 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | St. Mary's Medical Park Pharmacy | c32ccb5f-b9d7-0aff-e053-2995a90afe6d | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Redpharm Drug | 541bd97e-b2ff-09a8-e063-6394a90aee96 | 2026-06-13 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | 5af16acc-51ce-41ed-b1c4-6b3fb38ef515 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | a05035e1-f941-4f7c-9321-91dd50ab149b | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Cardinal Health 107, LLC | 922e9f5c-cc59-4d9e-bf42-a4b900d077ed | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | REMEDYREPACK INC. | 44b6cefc-7638-4437-95e7-8f239f66a9d4 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Preferred Pharmaceuticals Inc. | 18414c5a-8153-44f7-b27a-90c290af0a23 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | c2d8dcc9-23b0-75bb-e053-2995a90a02c8 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 3b9b15f7-354b-4049-982b-f6f31751a885 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 351b41db-622f-a1eb-e063-6294a90a5667 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | bf52e242-199b-4206-e053-2a95a90a1eb7 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | bf8d4359-a850-97b7-e053-2a95a90aa66a | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Major Pharmaceuticals | f818ed31-c746-4171-afdf-57a75434e5f1 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Cipro | CIPROFLOXACIN HYDROCHLORIDE | Bayer HealthCare Pharmaceuticals Inc. | 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Sportpharm LLC | 190395a8-c05f-4e31-9a89-7af6428ebbb9 | 2026-02-05 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 36d6c27d-45dc-3081-e063-6394a90a87e9 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |