Application 075593

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 750MG BASENoNo
002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo
003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo
004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075593-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09
A075593-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09
A075593-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075593-001AB
A075593-003AB
A075593-004AB

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 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09c2088c7a36db…
2026-10-15 13:18:302026-09A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09c2088c7a36db…
2026-10-15 13:18:302026-09A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09c2088c7a36db…
2026-09-14 22:38:342026-08A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A075593-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075593-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A075593-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A075593-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075593-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A075593-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A075593-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075593-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075593-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075593-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-001AB179d66fd596c7…

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 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1057be77-00bb-4839-be3d-c8e11ae531a22026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin Hydrochloride
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb2026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin Hydrochloride
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
brand name: Ciprofloxacin Hydrochloride
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEVERITYRX, LLC42542f65-84a7-fdab-e063-6394a90a10952025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin Hydrochloride
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
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack99918613-7936-47dd-8565-9cd6c0cc22e32025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.509b932e-9229-42c0-8a4c-f3257ffdca492025-03-29Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin Hydrochloride
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 2 of 2 · 102 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-9024CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9024CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9024CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9024CiprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0693CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-0693CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-0693CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-0693CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-0693CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-1090CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-1090CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-1090CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-1090CiprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70934-316CiprofloxacinCiprofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-316CiprofloxacinCiprofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-316CiprofloxacinCiprofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-316CiprofloxacinCiprofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
72189-242CIPROFLOXACINCIPROFLOXACINdirect rxANDACurrent
72189-242CIPROFLOXACINCIPROFLOXACINdirect rxANDACurrent
80425-0164CiproCiprofloxacin 500mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0164CiprofloxacinCiprofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0164CiprofloxacinCiprofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8731ORIG2004-06-15