Application 076710

Type
ANDA
Sponsor
DR REDDYS LABS INC

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
A076710-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2011-06-20
A076710-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2011-06-20
A076710-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076710-001AB
A076710-002AB
A076710-003AB

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 06:07:402026-07A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076710-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-201e350fbaab3a…

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 06:07:402026-07A076710-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076710-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076710-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076710-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076710-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076710-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076710-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076710-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076710-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076710-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076710-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076710-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076710-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076710-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076710-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076710-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076710-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076710-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076710-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076710-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076710-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076710-001AB11e350fbaab3a…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.710c0c10-89a5-4954-8f74-acc187c5cf0f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 70518-0932
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.f14cf651-a213-4a4f-adb9-f628562af27c2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 70518-0453
LevofloxacinLEVOFLOXACINCardinal Health 107, LLC070375be-3b67-4299-ae8f-4a7b157ac16f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 55154-5897
ndc (product): 55154-5898
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf2f090c2-3ee1-7689-e053-2995a90abe382026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf780bb91-483a-d1a6-e053-6294a90ab74b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf33140d5-59ad-3379-e053-2995a90ae2862026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 0904-6351
ndc (product): 0904-6352
ndc (product): 0904-6353
LevofloxacinLEVOFLOXACINGolden State Medical Supply, Inc.bfe280be-0789-69fa-e053-2a95a90a0e132024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 51407-428
ndc (product): 51407-429
ndc (product): 51407-430
LevofloxacinLEVOFLOXACINDr. Reddy's Laboratories Limited9b59428a-a23a-b2d9-982f-98f8a1ed381f2024-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076710
application number: ANDA076710
ndc (product): 55111-281
ndc (product): 55111-280
ndc (product): 55111-279

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6351LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
0904-6351LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
0904-6352LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
0904-6352LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
0904-6353LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
0904-6353LevofloxacinLevofloxacinMajor PharmaceuticalsANDACurrent
10544-245LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-558LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
50090-4928LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4928LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
51407-428LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
51407-428LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
51407-429LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
51407-429LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
51407-430LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
51407-430LevofloxacinLevofloxacinGolden State Medical Supply, Inc.ANDACurrent
55111-279LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-279LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-279LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-279LevofloxacinLevofloxacinDr. Reddy's Laboratories ANDACurrent
55111-279LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-280LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-280LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-280LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-280LevofloxacinLevofloxacinDr. Reddy's Laboratories ANDACurrent
55111-280LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-281LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-281LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-281LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55111-281LevofloxacinLevofloxacinDr. Reddy's Laboratories ANDACurrent
55111-281LevofloxacinLevofloxacinDr. Reddy's Laboratories LimitedANDACurrent
55154-5897LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5897LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5897LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5897LevofloxacinLevofloxacinCardinal Health 107, LLCANDACurrent
55154-5898LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5898LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5898LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-5898LevofloxacinLevofloxacinCardinal Health 107, LLCANDACurrent
55154-6898LevofloxacinLevofloxacinCardinal HealthANDACurrent
55154-6898LevofloxacinLevofloxacinCardinal HealthANDACurrent
67296-0977LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0977LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0977LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1325LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1325LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1325LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68788-9268LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0453LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0932LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0967LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0967LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
71335-1277LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-1277LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent