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 |
|---|---|---|---|---|---|---|
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | 9ee1f252-a64e-4b72-a6f7-60298e827222 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Sandoz Inc | ab52b14d-345b-47ff-a832-465caddd3801 | 2019-07-18 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | df24efa3-c9a0-4f40-92ce-cc71c708931b | 2018-10-31 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4e74496f-4dca-4471-be32-c0a14bc62750 | 2018-10-16 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.