Application 076426
- Type
- ANDA
- Sponsor
- PLIVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE | No | No |
| 003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 500MG BASE | No | No |
| 004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 750MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | ||
| A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | ||
| A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 |
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 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076426-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2005-06-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076426-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2005-06-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076426-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2005-06-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076426-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2005-06-15 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Cipro | CIPROFLOXACIN HYDROCHLORIDE | Bayer HealthCare Pharmaceuticals Inc. | 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Redpharm Drug | 4972e902-e042-e947-e063-6394a90a1b70 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 1057be77-00bb-4839-be3d-c8e11ae531a2 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Northwind Health Company, LLC | 2f123a2c-3f94-ca2d-e063-6394a90aff68 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Northwind Health Company, LLC | f80ab01d-2533-1b4c-e053-6294a90a6e6a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | cfda82e4-8660-447e-a881-b87165a31e9a | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | REMEDYREPACK INC. | a2cec2cc-729b-4baa-8df1-c3f70847a483 | 2025-11-05 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | VERITYRX, LLC | 42542f65-84a7-fdab-e063-6394a90a1095 | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 1dca6149-00ca-480e-a887-6861e40803b9 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Chartwell RX, LLC. | 6c64aa79-d087-4568-904c-3a0638b91e69 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 6e37322b-89d3-4b66-8e1b-c4ad79eed173 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | ac87e3c7-1e51-4dd1-8b75-dec6536810e3 | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | ec43739e-7154-45a7-add7-bfb8fb779be8 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3c611c8c-deed-4904-93f7-f75a2147fbf7 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | 7041828f-d4ec-4813-bcac-cb335c6c312a | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | 2b3b6a9f-259c-4736-b88f-f49d1eb64286 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | bb2edaca-6cf2-4100-83f5-8ce142f68e59 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | cc768d3e-a7cc-46a2-ae6d-0f5eb2f05406 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | d6bd5021-cf56-4c8a-b5a0-bbc8919740af | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.