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 | Direct Rx | d88a22f4-2f61-17f2-e053-2995a90acd14 | 2025-01-21 | Warnings, Adverse reactions | CIPROFLOXACIN CIPROFLOXACIN |
| CIPROFLOXACIN | CIPROFLOXACIN | DirectRx | d23e359d-6d12-38f6-e053-2a95a90a0a88 | 2025-01-20 | Warnings, Adverse reactions | CIPROFLOXACIN CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | DirectRx | d358eb18-f4d0-e9ba-e053-2a95a90a435d | 2025-01-20 | Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | Golden State Medical Supply, Inc. | 2e1addcf-6d5b-46c8-812b-558fd847f005 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFOLXACIN | Bryant Ranch Prepack | ab16bacd-f73f-462e-82b2-b0abb1c49cec | 2024-11-12 | 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 | CIPROFOLXACIN | Solco Healthcare US, LLC | b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3 | 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 | CIPROFLOXACIN | Amneal Pharmaceuticals NY LLC | b996e81b-36ec-4ad7-a7c4-bc6700a06648 | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | b283d662-9be1-49c7-be03-cb21055314c1 | 2024-10-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | A-S Medication Solutions | cfe9e173-1d3a-4455-a9d3-fb953bebbe37 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | NuCare Pharmaceuticals, Inc. | 238284a8-b38e-82af-e063-6394a90a79e1 | 2024-10-02 | 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 | CIPROFOLXACIN | Bryant Ranch Prepack | c9108da9-c271-4e9e-a035-8dd3019e8cf3 | 2024-09-23 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Bryant Ranch Prepack | 2b8288a2-18bf-423c-b175-33174be729d4 | 2024-08-15 | 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 | CIPROFLOXACIN | NuCare Pharmaceuticals, Inc. | 46dedf2c-26de-0f46-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b0136d72-0869-2da0-e053-2995a90af70a | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b064286b-fedc-be68-e053-2995a90aae52 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | 7def5a45-6725-0521-e053-2991aa0a0bda | 2024-06-12 | 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 |