Application 202801

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET;ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET;ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET;ORAL750MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202801-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2015-01-08
A202801-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2015-01-08
A202801-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2015-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202801-001AB
A202801-002AB
A202801-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-081e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202801-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202801-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202801-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202801-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-001AB11e350fbaab3a…

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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.c6027cde-b9fe-e593-e053-2995a90ac2c12025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINVERITYRX, LLC427a2077-5dbb-3c5e-e063-6294a90a08392025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINA-S Medication Solutions1538ec66-f385-401e-8cfb-d794691e71762025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINProficient Rx LP64141d0d-0347-470f-a427-9925a2eb357e2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 71205-002
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.05d179f5-b200-8597-e063-6394a90a10cc2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.80501b71-2f08-2ef5-e053-2991aa0a6e862025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINDirectRxdabedb15-5b55-3853-e053-2995a90aa44e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 72189-338
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.d98cf024-51fa-45a1-b247-da55aba88ca02025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 72789-248
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.8423b021-e09c-4f1c-e053-2991aa0afef62025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4b7333-4f77-4ec9-e053-2a95a90a16d22024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 80425-0007
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCb001d60e-b8fb-54ff-e053-2a95a90a29702024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 80425-0077
LevofloxacinLEVOFLOXACINA-S Medication Solutionsbdc8b2cc-a914-4613-ac7c-e8dfe91dea132024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINBryant Ranch Prepack171ab6c6-8eb5-4716-926f-cee52b7d09682024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 71335-0794

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 117 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70934-094LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-094LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-094LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-094LevofloxacinLevofloxacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-094LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-641LevofloxacinLevofloxacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-002LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71205-002LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71205-002LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71205-002LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71205-002LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71335-0434LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0434LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0434LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0434LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0593LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0593LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0593LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0593LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0794LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0794LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0794LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0794LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
72189-338LevofloxacinLevofloxacinDirectRxANDACurrent
72189-338LevofloxacinLevofloxacinDirectRxANDACurrent
72789-248LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-248LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-248LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
80425-0007LevaquinLevofloxacinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0007LevaquinLevofloxacinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0007LevofloxacinLevofloxacinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0007LevofloxacinLevofloxacinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0007LevofloxacinLevofloxacinADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0077LevaquinLevofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0077LevofloxacinLevofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0077LevofloxacinLevofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0077LevofloxacinLevofloxacinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10111ORIG2015-01-12