Application 075817
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | ||
| A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | |
| A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075817-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075817-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075817-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | 2004-06-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075817-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2007-06-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075817-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | 2004-06-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075817-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075817-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075817-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075817-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075817-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075817-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075817-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075817-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075817-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075817-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075817-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075817-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075817-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075817-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075817-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075817-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075817-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075817-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075817-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075817-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075817-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075817-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075817-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075817-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075817-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075817-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075817-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075817-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075817-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075817-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075817-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075817-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075817-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075817-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075817-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075817-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075817-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075817-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075817-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075817-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A075817-003 | AB | 1 | e64feba35796… |
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 Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Coupler LLC | 58388197-82f4-0953-e063-6294a90ac52a | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | b281a5c0-5f3e-4e6f-86ac-ed7794aac64c | 2026-08-01 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Redpharm Drug | 57e5832f-9168-1f24-e063-6294a90aaae6 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc | b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 14c3bc33-201d-492e-9aee-a4d84c813a3d | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | HAWAII REPACK, INC. | 0fe3becb-f90e-4187-a8e8-bd0de5a79ad2 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | a2ffa81a-86c5-40b9-8fa0-c889801ef479 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | a914512b-9a4a-4c53-ab7a-2e2b1ea8a012 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | REMEDYREPACK INC. | 47d1e4c5-f669-4aca-9e8c-0d6bb833b859 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | 6a935846-3c97-4517-bc4e-2377f673285e | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Redpharm Drug | 1ac4540c-d0f7-70bc-e063-6394a90a0f7a | 2026-05-05 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 4dd69fb7-802a-4278-a730-c722a3ca3521 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | d8b21832-b74f-4f85-a304-b907c9e01e72 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 9d83b127-ef13-4b2c-aa30-0f54937dc240 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | American Health Packaging | 275de35b-5c97-4ff8-a571-42e23c1cd83e | 2026-05-03 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Asclemed USA, Inc. | ae77a5c0-a2ae-770c-e053-2a95a90a6a96 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 26e2d370-f59c-40ae-9c1e-7f8bf1f9fde4 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | American Health Packaging | 0fac4466-fbe5-49d2-96e3-e3ac2739bd5b | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
| Ciprofloxacin Hydrochloride | CIPROFLOXACIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 78641acd-eedf-4b68-bb18-da0874415f59 | 2026-03-27 | Warnings, Adverse reactions | Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE |
| CIPROFLOXACIN | CIPROFLOXACIN HYDROCHLORIDE | DIRECT RX | a7e5174a-dd01-6050-e053-2a95a90add3f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | CIPROFLOXACIN HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7098 | Ciprofloxacin | ciprofloxacin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 10544-605 | Ciprofloxacin | ciprofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 11819-363 | Ciprofloxacin | ciprofloxacin | HHS/Program Support Center/Supply Service Center | ANDA | Current |
| 51079-182 | Ciprofloxacin | ciprofloxacin | Mylan Institutional Inc. | ANDA | Current |
| 55154-5376 | Ciprofloxacin | ciprofloxacin | Cardinal Health | ANDA | Current |
| 68645-060 | Ciprofloxacin | ciprofloxacin | Legacy Pharmaceutical Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8796 | ORIG | 2004-06-24 |