FDA.reportPublic FDA data

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 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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0884e616aacf4f…
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…

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 22:38:342026-08A202801-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202801-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202801-003AB184e616aacf4f…
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…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINBryant Ranch Prepack54a02488-586d-4c4e-8a35-68a067bdd6e32024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINBryant Ranch Prepack804ec547-5b89-4fd0-89b3-7445543e563e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINCamber Pharmaceuticals, Inc.b43e9b51-568c-4d84-bbd1-d237120056c42024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 31722-722
ndc (product): 31722-723
ndc (product): 31722-721
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals, Inc.4a405103-41e8-6a1f-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 68071-3093
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.631523e7-7d67-0cc3-e053-2a91aa0abb622024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 68071-3218
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 68071-4512
LevofloxacinLEVOFLOXACINProficient Rx LP95149cfb-1a71-42b7-b50d-9a2e943343392022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
ndc (product): 63187-833

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 2 · 117 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-721LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-722LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-723LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3311LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3314LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3314LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
53002-1350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1641LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1641LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68071-1860LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1860LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2074LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3166LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3166LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,InANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4547LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7037LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7037LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc.ANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

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