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 | CIPROFOLXACIN | Proficient Rx LP | 0ce2221d-940f-4c07-ba2e-fccb491f6b9b | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | 69df48cc-76b6-428e-891a-c25e07d785f8 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Bryant Ranch Prepack | a5ecc693-b8fd-4a7a-8040-e56f801c9353 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFOLXACIN | Coupler LLC | 3134401f-72a3-6c37-e063-6294a90a8fa9 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| ciprofloxacin | CIPROFLOXACIN | Advanced Rx of Tennessee, LLC | 30cb2b42-aa4b-8cec-e063-6394a90aa615 | 2025-03-20 | Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Coupler LLC | 2fff7a38-2c4e-d343-e063-6294a90aca3c | 2025-03-10 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| ciprofloxacin | CIPROFLOXACIN | Umasuto, LLC | 0c355077-7361-41d0-9e82-eb31beaf5daa | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 1cb05412-372e-4b49-92e1-532caa05f38f | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | Direct_Rx | 2efbda2a-fc97-b7c5-e063-6294a90a362d | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | d17b0e87-b555-4dfb-e053-2a95a90aa5ef | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 1b54c195-71ba-2523-e063-6294a90ada73 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | fa32aafd-e3f5-4be6-9413-c7663c1c2cec | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 5723eaf9-8659-4730-b792-4e4c33690ccb | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | d275175c-691a-4d09-bbb7-50ee819e6727 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin CIPROFLOXACIN |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Carlsbad Technology, Inc. | 37527eca-115e-4582-88cd-bba851ac6069 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Coupler LLC | 2d6ad813-7773-9e20-e063-6294a90a112d | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFOLXACIN | Advanced Rx of Tennessee, LLC | 2d324cb1-8567-55e5-e063-6294a90aa5d9 | 2025-02-02 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN TABLETS | Bryant Ranch Prepack | 7030109d-5ce0-43f1-a5ed-16a3562acd40 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN TABLETS | Bryant Ranch Prepack | 8d6ec3ee-2205-4d78-bc48-d39f371797c1 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin |
| Ciprofloxacin | CIPROFLOXACIN | Redpharm Drug | 17435f05-f04d-e792-e063-6294a90af145 | 2025-01-23 | 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 |