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 | Bryant Ranch Prepack | 99918613-7936-47dd-8565-9cd6c0cc22e3 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Asclemed USA, Inc. | 509b932e-9229-42c0-8a4c-f3257ffdca49 | 2025-03-29 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30caadee-3255-e0e3-e063-6294a90a8061 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | Advagen Pharma Limited | 74af98f1-eb6d-473b-94a9-67920dba8c3d | 2025-03-11 | Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 1cb05412-372e-4b49-92e1-532caa05f38f | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | d17b0e87-b555-4dfb-e053-2a95a90aa5ef | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 1b54c195-71ba-2523-e063-6294a90ada73 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Carlsbad Technology, Inc. | 37527eca-115e-4582-88cd-bba851ac6069 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 5cf0f572-48fc-6a3a-e053-2991aa0a8437 | 2025-02-03 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6301febb-01aa-1af5-e053-2991aa0aa309 | 2025-02-03 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | ec3a3dcf-b9c9-432e-adfe-4b30cade8931 | 2024-11-07 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | b283d662-9be1-49c7-be03-cb21055314c1 | 2024-10-24 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 694b79f6-599f-4a71-bf02-d0d09767a735 | 2024-10-01 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | Sandoz Inc | 09ca5374-2a16-4a95-91b3-70591d78254e | 2024-07-30 | Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 54c73290-bd89-3453-e054-00144ff88e88 | 2024-07-10 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | ec337816-4f48-4d04-b91d-60f9f5f634da | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | 8eef4f14-e7ef-41be-be57-7993b333e8a9 | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | e04dfddd-6177-4c2e-8f42-acd65848e6e2 | 2022-12-01 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin HCl Ophthalmic | CIPROFLOXACIN HYDROCHLORIDE | Altaire Pharmaceuticals Inc. | 41363a06-d6f5-4bc6-b0e9-34e5616ae387 | 2022-10-28 | Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | a093ca6e-9963-4eea-b60d-6e2f148192ec | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.