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 | Umasuto, LLC | 0c355077-7361-41d0-9e82-eb31beaf5daa | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 2efbda2a-fc97-b7c5-e063-6294a90a362d | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | fa32aafd-e3f5-4be6-9413-c7663c1c2cec | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 5723eaf9-8659-4730-b792-4e4c33690ccb | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | d275175c-691a-4d09-bbb7-50ee819e6727 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Redpharm Drug | 17435f05-f04d-e792-e063-6294a90af145 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| CIPROFLOXACIN | CIPROFLOXACIN | Direct Rx | d88a22f4-2f61-17f2-e053-2995a90acd14 | 2025-01-21 | Warnings, Adverse reactions | CIPROFLOXACIN |
| CIPROFLOXACIN | CIPROFLOXACIN | DirectRx | d23e359d-6d12-38f6-e053-2a95a90a0a88 | 2025-01-20 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | DirectRx | d358eb18-f4d0-e9ba-e053-2a95a90a435d | 2025-01-20 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Golden State Medical Supply, Inc. | 2e1addcf-6d5b-46c8-812b-558fd847f005 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Hikma Pharmaceuticals USA Inc. | 3b3d22dc-df09-4910-8c9b-1204eeedbd68 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Teva Pharmaceuticals USA, Inc. | 3e4402d4-e0d3-9846-3e81-ed46f34137fe | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Amneal Pharmaceuticals NY LLC | b996e81b-36ec-4ad7-a7c4-bc6700a06648 | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | A-S Medication Solutions | 766251ac-2040-4a79-9ca5-a1e5f1e01cb5 | 2024-10-01 | Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Sagent Pharmaceuticals | f406e796-17d9-4465-b8a7-00d966a4ba74 | 2024-09-27 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals, Inc. | 44e5582d-fff1-0ec9-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals, Inc. | 46dedf2c-26de-0f46-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b0136d72-0869-2da0-e053-2995a90af70a | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b064286b-fedc-be68-e053-2995a90aae52 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | 7def5a45-6725-0521-e053-2991aa0a0bda | 2024-06-12 | Warnings, Adverse reactions | CIPROFLOXACIN |