Application 077753
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | INJECTABLE;INJECTION | 200MG/100ML | No | Yes |
| 002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | INJECTABLE;INJECTION | 400MG/200ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 |
| A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077753-001 | AP |
| A077753-002 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077753-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077753-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | RS | 2008-03-18 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077753-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077753-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077753-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077753-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077753-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077753-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077753-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077753-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077753-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077753-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077753-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077753-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077753-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077753-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077753-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077753-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077753-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077753-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077753-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077753-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077753-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077753-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077753-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077753-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077753-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077753-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077753-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077753-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077753-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077753-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077753-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077753-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077753-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077753-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077753-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077753-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077753-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077753-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077753-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077753-002 | AP | 1 | bb7c543d1eb4… |
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. | 44b6cefc-7638-4437-95e7-8f239f66a9d4 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| 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 | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 0409-4777 | CIPROFLOXACIN | CIPROFLOXACIN | Hospira, Inc. | ANDA | Current |
| 55154-7828 | CIPROFLOXACIN | CIPROFLOXACIN | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9078 | ORIG | 2008-03-19 |