Application 076089

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACINCIPROFLOXACINTABLET; ORAL100MGNoNo
002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo
003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDETABLET;ORALEQ 750MG BASENoNo

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

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
A076089-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09
A076089-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09
A076089-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG 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
A076089-002AB
A076089-003AB
A076089-004AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076089-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076089-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076089-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076089-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A076089-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076089-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076089-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076089-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076089-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076089-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076089-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076089-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076089-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076089-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076089-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076089-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076089-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076089-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076089-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076089-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076089-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076089-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076089-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076089-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076089-002AB1301d65b070ca…

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited6a935846-3c97-4517-bc4e-2377f673285e2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionsd8b21832-b74f-4f85-a304-b907c9e01e722026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions9d83b127-ef13-4b2c-aa30-0f54937dc2402026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging275de35b-5c97-4ff8-a571-42e23c1cd83e2026-05-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.ae77a5c0-a2ae-770c-e053-2a95a90a6a962026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFOLXACINSportpharm LLCd38b5160-4c1c-41d9-8f13-f9f877778f9c2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFOLXACINREMEDYREPACK INC.4edc4fda-7834-46cc-a0ed-22f117e6e10b2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging0fac4466-fbe5-49d2-96e3-e3ac2739bd5b2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFOLXACINProficient Rx LP9f00ae9d-8707-4275-9eba-2ed72db8aea12026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFOLXACINPreferred Pharmaceuticals Inc.4425d454-210d-4b9f-88ad-6b32a9e0d3bd2026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACINPreferred Pharmaceuticals Inc.18414c5a-8153-44f7-b27a-90c290af0a232026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.c2d8dcc9-23b0-75bb-e053-2995a90a02c82026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.3b9b15f7-354b-4049-982b-f6f31751a8852026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINDirect_Rx351b41db-622f-a1eb-e063-6294a90a56672026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDEDIRECT RXa7e5174a-dd01-6050-e053-2a95a90add3f2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf52e242-199b-4206-e053-2a95a90a1eb72026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf8d4359-a850-97b7-e053-2a95a90aa66a2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ciprofloxacin
generic name: CIPROFLOXACIN
CiproCIPROFLOXACIN HYDROCHLORIDEBayer HealthCare Pharmaceuticals Inc.888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c02026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-5312CiprofloxacinCiprofloxacinTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-606Ciprofloxacin hydrochlorideCiprofloxacin hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
53808-0223Ciprofloxacin hydrochlorideCiprofloxacin hydrochlorideState of Florida DOH Central PharmacyANDACurrent
66116-508Ciprofloxacin HydrochlorideCiprofloxacin HydrochlorideMedVantx, Inc.ANDACurrent
67296-0543CIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochloride tabletRedPharm Drug Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31073ORIG2004-06-15