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 | QPharma, Inc. | 4149d980-a6cd-c06d-e063-6394a90a47a1 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFOLXACIN | NuCare Pharmaceuticals,Inc. | 41206a0f-7a5b-6a12-e063-6394a90a58b1 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Chartwell RX, LLC. | 6c64aa79-d087-4568-904c-3a0638b91e69 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 6e37322b-89d3-4b66-8e1b-c4ad79eed173 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | ac87e3c7-1e51-4dd1-8b75-dec6536810e3 | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | PD-Rx Pharmaceuticals, Inc. | 3b3c0874-90b7-deda-e063-6394a90a7802 | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | ec43739e-7154-45a7-add7-bfb8fb779be8 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3c611c8c-deed-4904-93f7-f75a2147fbf7 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7041828f-d4ec-4813-bcac-cb335c6c312a | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | 2b3b6a9f-259c-4736-b88f-f49d1eb64286 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| ciprofloxacin | CIPROFLOXACIN | Rising Pharma Holdings, Inc. | ef468722-68cd-440b-afd7-2285029db41f | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 2491e6a9-3415-43b9-b31b-67331f52806a | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | e81341c6-0e25-4860-adda-2d3cebe88d62 | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 178dc379-e2b8-4b47-9f0c-3fc7fb435c36 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFOLXACIN | Preferred Pharmaceuticals Inc. | 15755a35-e29a-47c1-89ab-e6645bb3ade9 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | bb2edaca-6cf2-4100-83f5-8ce142f68e59 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | cc768d3e-a7cc-46a2-ae6d-0f5eb2f05406 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| ciprofloxacin | CIPROFLOXACIN | A-S Medication Solutions | c12b316f-811c-48b6-a320-d314991aa74f | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | d6bd5021-cf56-4c8a-b5a0-bbc8919740af | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | 99918613-7936-47dd-8565-9cd6c0cc22e3 | 2025-04-01 | 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 |