Application 077245
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN | CIPROFLOXACIN | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) | No | No |
| 002 | CIPROFLOXACIN | CIPROFLOXACIN | INJECTABLE;INJECTION | 400MG/40ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077245-001 | CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | ||
| A077245-002 | CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 |
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 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | 2006-08-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077245-001 | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2006-08-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077245-002 | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE / INJECTION | AP | 2006-08-28 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077245-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077245-002 | AP | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077245-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077245-002 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077245-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077245-002 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077245-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077245-002 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077245-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077245-002 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077245-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077245-002 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077245-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077245-002 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077245-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077245-002 | AP | 1 | 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 | Sportpharm LLC | 190395a8-c05f-4e31-9a89-7af6428ebbb9 | 2026-02-05 | Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 36d6c27d-45dc-3081-e063-6394a90a87e9 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Preferred Pharmaceuticals, Inc. | 85c48ebc-d94a-4254-86df-d2c1aff09b37 | 2026-01-13 | Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Northwind Health Company, LLC | 2f123a2c-3f94-ca2d-e063-6394a90aff68 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Northwind Health Company, LLC | f80ab01d-2533-1b4c-e053-6294a90a6e6a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | Northwind Health Company, LLC | f6debb60-d885-230b-e053-6394a90ad73a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Northwind Health Company, LLC | f67d727f-b9ca-aec0-e053-2995a90aab69 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN TABLETS | Yiling Pharmaceutical, Inc. | 6fd3da0b-7428-ac8f-e053-2a91aa0aed9f | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Redpharm Drug | 3253a41f-4f0a-5d83-e063-6294a90a890c | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | NuCare Pharmaceutical, Inc. | 24760182-4be8-9f43-e063-6294a90a269e | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Redpharm Drug | 3b0af0f2-1d33-1ffe-e063-6394a90aca7c | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | QPharma Inc | 4d5afeff-3917-43e1-9d12-d70ccab00dcc | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Chartwell RX, LLC | 905503ef-4277-44ca-aa4a-5a969a041e16 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFOLXACIN | NuCare Pharmaceuticals,Inc. | 1b189dba-0493-c9b4-e063-6294a90a7d1e | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | cfda82e4-8660-447e-a881-b87165a31e9a | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin in Dextrose | CIPROFLOXACIN | ProPharma Distribution | 42c758be-4d44-018a-e063-6294a90ae041 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin in Dextrose | CIPROFLOXACIN | Hospira, Inc. | cbbbf939-3219-4515-a48e-ca264daa4d07 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 1dca6149-00ca-480e-a887-6861e40803b9 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | Method Pharmaceuticals, LLC | acb03e72-ce94-58c5-e053-2a95a90a683a | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin 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 |
|---|---|---|---|---|---|
| 21695-914 | Ciprofloxacin | Ciprofloxacin | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9025 | ORIG | 2006-09-18 |