Application 076794
- Type
- ANDA
- Sponsor
- WATSON LABS
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 |
|---|---|---|---|---|---|---|---|
| A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | |
| A076794-003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | |
| A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076794-002 | AB |
| A076794-003 | AB |
| A076794-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076794-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2005-02-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-003 | 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 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2005-02-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076794-001 | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | 2005-02-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076794-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076794-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076794-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076794-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076794-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076794-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076794-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076794-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076794-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076794-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076794-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076794-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076794-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076794-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076794-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076794-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076794-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076794-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076794-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076794-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076794-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076794-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076794-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076794-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076794-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076794-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076794-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076794-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076794-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076794-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076794-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076794-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076794-002 | AB | 1 | 8072bd15b7f6… |
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 | Teva Pharmaceuticals USA, Inc. | 3e4402d4-e0d3-9846-3e81-ed46f34137fe | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | 076794 ANDA076794 16252-514 16252-516 16252-515 |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b0136d72-0869-2da0-e053-2995a90af70a | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 076794 ANDA076794 68071-2267 |
| Ciprofloxacin | CIPROFLOXACIN | NuCare Pharmaceuticals,Inc. | b064286b-fedc-be68-e053-2995a90aae52 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 076794 ANDA076794 68071-2269 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-147 | Ciprofloxacin | Ciprofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 11819-323 | Ciprofloxacin | ciprofloxacin hydrochloride | HHS/Program Support Center/Supply Service Center | ANDA | Current |
| 11819-351 | Ciprofloxacin | ciprofloxacin hydrochloride | HHS/Program Support Center/Supply Service Center | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-514 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-515 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 16252-516 | Ciprofloxacin | Ciprofloxacin | Actavis Pharma, Inc. | ANDA | Current |
| 21695-210 | Ciprofloxacin | ciprofloxacin hydrochloride | Rebel Distributors Corp. | ANDA | Current |
| 21695-411 | Ciprofloxacin | ciprofloxacin hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 42708-002 | Ciprofloxacin | Ciprofloxacin | QPharma Inc | ANDA | Current |
| 42708-002 | Ciprofloxacin | Ciprofloxacin | QPharma Inc | ANDA | Current |
| 42708-002 | Ciprofloxacin | Ciprofloxacin | QPharma Inc | ANDA | Current |
| 42708-002 | Ciprofloxacin | Ciprofloxacin | QPharma Inc | ANDA | Current |
| 50090-1685 | Ciprofloxacin | Ciprofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-1685 | Ciprofloxacin | Ciprofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-1685 | Ciprofloxacin | Ciprofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-5382 | Ciprofloxacin | Ciprofloxacin | A-S Medication Solutions | ANDA | Current |
| 50436-6041 | Ciprofloxacin | Ciprofloxacin | Unit Dose Services | ANDA | Current |
| 52959-730 | Ciprofloxacin | ciprofloxacin hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-734 | Ciprofloxacin | ciprofloxacin hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-739 | Ciprofloxacin | ciprofloxacin hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53401-005 | ciprofloxacin hydrochloride | ciprofloxacin hydrochloride | Testpak Holding Company | ANDA | Current |
| 53808-0349 | Ciprofloxacin | ciprofloxacin hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-2081 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2081 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2081 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2086 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2086 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2086 | Ciprofloxacin | ciprofloxacin hydrochloride | Cardinal Health | ANDA | Current |
| 67296-0580 | Ciprofloxacin | ciprofloxacin hydrochloride | RedPharm Drug Inc. | ANDA | Current |
| 67296-0608 | Ciprofloxacin | ciprofloxacin hydrochloride | RedPharm Drug Inc. | ANDA | Current |
| 68071-2267 | Ciprofloxacin | Ciprofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2267 | Ciprofloxacin | Ciprofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2269 | Ciprofloxacin | Ciprofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2269 | Ciprofloxacin | Ciprofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-069 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-069 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-069 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-069 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-070 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-071 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-071 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-071 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-071 | Ciprofloxacin | Ciprofloxacin Hydrochloride | American Health Packaging | ANDA | Current |
| 68788-7857 | Ciprofloxacin | Ciprofloxacin | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-8088 | Ciprofloxacin | Ciprofloxacin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8088 | Ciprofloxacin | Ciprofloxacin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9330 | Ciprofloxacin | Ciprofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70934-623 | Ciprofloxacin | Ciprofloxacin | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-1393 | Ciprofloxacin | Ciprofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1393 | Ciprofloxacin | Ciprofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1393 | Ciprofloxacin | Ciprofloxacin | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8964 | ORIG | 2004-06-15 |