FDA.reportPublic FDA data

Application 201043

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET;ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET;ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET;ORAL750MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201043-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2011-06-20
A201043-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2011-06-20
A201043-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201043-001AB
A201043-002AB
A201043-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201043-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201043-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201043-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201043-001AB18072bd15b7f6…

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINHAWAII REPACK, INC.857f256c-88ac-4f73-9815-c2724edf2f1e2026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
ndc (product): 43063-457
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.814450ae-439e-4a5d-8c60-9b21b6f14be52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
ndc (product): 43063-459
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b1a4aabb-42af-4133-8e82-0c7ec8fa79c32025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b8defac4-9deb-433b-928e-0ef4ee0123a22025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCafd5cb35-4232-f8b1-e053-2a95a90a8c5b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
ndc (product): 65862-537
ndc (product): 65862-536
ndc (product): 65862-538
LevofloxacinLEVOFLOXACINAsclemed USA, Inc.2e32a8aa-047b-46c6-b67b-d88a9a0a810b2024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINProficient Rx LP30958610-3803-45e6-aa3c-d256decbe6e42019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
ndc (product): 71205-058

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 87 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-624LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
42708-122LevofloxacinLevofloxacinQPharma IncANDACurrent
42708-122LevofloxacinLevofloxacinQPharma IncANDACurrent
42708-122LevofloxacinLevofloxacinQPharma IncANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-457LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-459LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-459LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-459LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-459LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-459LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1227LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-1228LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-1228LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-2498LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-2498LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
52343-119LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-119LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-119LevofloxacinLevofloxacinLUCID PHARMA LLCANDACurrent
52343-120LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-120LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-120LevofloxacinLevofloxacinLUCID PHARMA LLCANDACurrent
52343-121LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-121LevofloxacinLevofloxacinACETRIS HEALTH, LLCANDACurrent
52343-121LevofloxacinLevofloxacinLUCID PHARMA LLCANDACurrent
53002-2350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
57237-066LevofloxacinLevofloxacinCitron Pharma LLCANDACurrent
57237-067LevofloxacinLevofloxacinCitron Pharma LLCANDACurrent
57237-068LevofloxacinLevofloxacinCitron Pharma LLCANDACurrent
61919-987LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-987LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
64205-537LevofloxacinLevofloxacinReadyMedsANDACurrent
64980-366LevofloxacinLevofloxacinRising Pharmaceuticals, Inc.ANDACurrent
64980-367LevofloxacinLevofloxacinRising Pharmaceuticals, Inc.ANDACurrent
64980-368LevofloxacinLevofloxacinRising Pharmaceuticals, Inc.ANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-536LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-537LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
65862-538LevofloxacinLevofloxacinAurobindo Pharma LimitedANDACurrent
67296-0897LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0897LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0897LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0998LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68071-4900LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4900LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4925LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9548LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9707LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0846LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0846LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
71205-058LevofloxacinLevofloxacinProficient Rx LPANDACurrent
71205-058LevofloxacinLevofloxacinProficient Rx LPANDACurrent