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 HYDROCHLORIDE | Aurobindo Pharma Limited | 6a935846-3c97-4517-bc4e-2377f673285e | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | d8b21832-b74f-4f85-a304-b907c9e01e72 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 9d83b127-ef13-4b2c-aa30-0f54937dc240 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | American Health Packaging | 275de35b-5c97-4ff8-a571-42e23c1cd83e | 2026-05-03 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Asclemed USA, Inc. | ae77a5c0-a2ae-770c-e053-2a95a90a6a96 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Sportpharm LLC | d38b5160-4c1c-41d9-8f13-f9f877778f9c | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | REMEDYREPACK INC. | 4edc4fda-7834-46cc-a0ed-22f117e6e10b | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 26e2d370-f59c-40ae-9c1e-7f8bf1f9fde4 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | American Health Packaging | 0fac4466-fbe5-49d2-96e3-e3ac2739bd5b | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Proficient Rx LP | 9f00ae9d-8707-4275-9eba-2ed72db8aea1 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Preferred Pharmaceuticals Inc. | 4425d454-210d-4b9f-88ad-6b32a9e0d3bd | 2026-03-30 | 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 | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | c2d8dcc9-23b0-75bb-e053-2995a90a02c8 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 3b9b15f7-354b-4049-982b-f6f31751a885 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 351b41db-622f-a1eb-e063-6294a90a5667 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| CIPROFLOXACIN | CIPROFLOXACIN HYDROCHLORIDE | DIRECT RX | a7e5174a-dd01-6050-e053-2a95a90add3f | 2026-03-05 | 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 | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | bf8d4359-a850-97b7-e053-2a95a90aa66a | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Major Pharmaceuticals | f818ed31-c746-4171-afdf-57a75434e5f1 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Cipro | CIPROFLOXACIN HYDROCHLORIDE | Bayer HealthCare Pharmaceuticals Inc. | 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 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 |