FDA.reportPublic FDA data

Application 200839

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
A200839-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-03-22
A200839-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-03-22
A200839-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200839-001AB
A200839-002AB
A200839-003AB

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 06:07:402026-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-221e350fbaab3a…

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 06:07:402026-07A200839-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001AB11e350fbaab3a…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839
LevofloxacinLEVOFLOXACINMacleods Pharmaceuticals Limitedfc165a6d-24b0-4753-a7ac-94a134dca0d32023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839
ndc (product): 33342-533
ndc (product): 33342-532
ndc (product): 33342-531

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 154 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-143LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-906LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
12634-674LevofloxacinLevofloxacinApotheca Inc.ANDACurrent
12634-675LevofloxacinLevofloxacinApotheca Inc.ANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-531LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-532LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-533LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, InANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-4572LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4572LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4573LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4573LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4797LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4797LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50436-0022LevofloxacinLevofloxacinUnit Dose ServicesANDACurrent
51655-249LevofloxacinLevofloxacinNorthwind PharmaceuticalsANDACurrent
51655-250LevofloxacinLevofloxacinNorthwind PharmaceuticalsANDACurrent
53002-1391LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2582LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-3350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53217-199LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
54348-611LevofloxacinLEVOFLOXACINPharmPak, Inc.ANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
58118-1022LevofloxacinLevofloxacinClinical Solutions Wholesale, LLCANDACurrent
58118-1022LevofloxacinLevofloxacinClinical Solutions Wholesale, LLCANDACurrent
61919-359LEVAQUINLEVOFLOXACINDIRECT RXANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirectRXANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-741LevofloxacinLevofloxacinDirect RxANDACurrent
63187-438LevofloxacinLevofloxacinProficient Rx LPANDACurrent