FDA.reportPublic FDA data

Application 021744

Type
NDA
Sponsor
DEPOMED INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROQUIN XRCIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 500MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021744-001PROQUIN XRCIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1984e616aacf4f…
2026-08-18 06:07:402026-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193f01610625f2…
2019-09-15 20:21 UTC2019-09N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021744-001PROQUIN XREQ 500MG BASETABLET, EXTENDED RELEASE / ORAL2005-05-19f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021744-00164889622020-06-20Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021744-00164889622020-06-20Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021744-00164889622020-06-20Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021744-00164889622020-06-20Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021744-00164889622020-06-20Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021744-00164889622020-06-20Drug productea99ee380514…

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.

Matched openFDA labels page 2 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiproCIPROFLOXACIN HYDROCHLORIDEBayer HealthCare Pharmaceuticals Inc.888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c02026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDERedpharm Drug4972e902-e042-e947-e063-6394a90a1b702026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1057be77-00bb-4839-be3d-c8e11ae531a22026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb2026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLC2f123a2c-3f94-ca2d-e063-6394a90aff682026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLCf80ab01d-2533-1b4c-e053-6294a90a6e6a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cfda82e4-8660-447e-a881-b87165a31e9a2025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.a2cec2cc-729b-4baa-8df1-c3f70847a4832025-11-05Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEVERITYRX, LLC42542f65-84a7-fdab-e063-6394a90a10952025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1dca6149-00ca-480e-a887-6861e40803b92025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEChartwell RX, LLC.6c64aa79-d087-4568-904c-3a0638b91e692025-10-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions6e37322b-89d3-4b66-8e1b-c4ad79eed1732025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac87e3c7-1e51-4dd1-8b75-dec6536810e32025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackec43739e-7154-45a7-add7-bfb8fb779be82025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c611c8c-deed-4904-93f7-f75a2147fbf72025-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited7041828f-d4ec-4813-bcac-cb335c6c312a2025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited2b3b6a9f-259c-4736-b88f-f49d1eb642862025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.bb2edaca-6cf2-4100-83f5-8ce142f68e592025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionscc768d3e-a7cc-46a2-ae6d-0f5eb2f054062025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackd6bd5021-cf56-4c8a-b5a0-bbc8919740af2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13913-001Proquinciprofloxacin hydrochlorideDepomed, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52755ORIG2018-02-28
16296SUPPL2011-03-04
6106SUPPL2011-03-03
24007ORIG2011-01-13
16295SUPPL2011-01-04
6105SUPPL2011-01-04
28508SUPPL2009-05-13
37572SUPPL2009-05-11
6104SUPPL2008-10-23
6103SUPPL2008-10-23
37571SUPPL2008-10-09
28507SUPPL2008-10-08
42295ORIG2007-09-11
37570SUPPL2007-09-06
28506SUPPL2007-09-06
16294SUPPL2007-08-14
16293SUPPL2007-08-02
6102SUPPL2007-08-02
28505SUPPL2006-08-21
37569SUPPL2006-08-18
37568ORIG2005-05-20
6101ORIG2005-05-20