Application 021744
- Type
- NDA
- Sponsor
- DEPOMED INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROQUIN XR | CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021744-001 | PROQUIN XR | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 |
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 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021744-001 | PROQUIN XR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2005-05-19 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021744-001 | 6488962 | 2020-06-20 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021744-001 | 6488962 | 2020-06-20 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021744-001 | 6488962 | 2020-06-20 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021744-001 | 6488962 | 2020-06-20 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021744-001 | 6488962 | 2020-06-20 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021744-001 | 6488962 | 2020-06-20 | Drug product | ea99ee380514… |
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 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13913-001 | Proquin | ciprofloxacin hydrochloride | Depomed, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 52755 | ORIG | 2018-02-28 |
| 16296 | SUPPL | 2011-03-04 |
| 6106 | SUPPL | 2011-03-03 |
| 24007 | ORIG | 2011-01-13 |
| 16295 | SUPPL | 2011-01-04 |
| 6105 | SUPPL | 2011-01-04 |
| 28508 | SUPPL | 2009-05-13 |
| 37572 | SUPPL | 2009-05-11 |
| 6104 | SUPPL | 2008-10-23 |
| 6103 | SUPPL | 2008-10-23 |
| 37571 | SUPPL | 2008-10-09 |
| 28507 | SUPPL | 2008-10-08 |
| 42295 | ORIG | 2007-09-11 |
| 37570 | SUPPL | 2007-09-06 |
| 28506 | SUPPL | 2007-09-06 |
| 16294 | SUPPL | 2007-08-14 |
| 16293 | SUPPL | 2007-08-02 |
| 6102 | SUPPL | 2007-08-02 |
| 28505 | SUPPL | 2006-08-21 |
| 37569 | SUPPL | 2006-08-18 |
| 37568 | ORIG | 2005-05-20 |
| 6101 | ORIG | 2005-05-20 |