Home Applications 200839 Application 200839
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVOFLOXACIN LEVOFLOXACIN TABLET;ORAL 250MG No No 002 LEVOFLOXACIN LEVOFLOXACIN TABLET;ORAL 500MG No No 003 LEVOFLOXACIN LEVOFLOXACIN TABLET;ORAL 750MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200839-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 A200839-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 A200839-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 154 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63187-438 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-438 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-438 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-438 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-438 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63629-8070 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 63629-8070 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 63629-8162 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 67296-0972 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0972 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0972 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0975 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0975 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0975 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0985 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0985 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-0985 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 68071-1932 Levofloxacin Levofloxacin NuCare Pharmaceuticals, Inc. ANDA Current 68071-3051 Levofloxacin Levofloxacin NuCare Pharmaceuticals, Inc. ANDA Current 68071-3236 Levofloxacin Levofloxacin NuCarePharmaceuticals, Inc. ANDA Current 68071-3236 Levofloxacin Levofloxacin NuCarePharmaceuticals, Inc. ANDA Current 68071-3236 Levofloxacin Levofloxacin NuCarePharmaceuticals, Inc. ANDA Current 68071-4422 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4422 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4726 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4726 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4726 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4874 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4874 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4875 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4875 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4926 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4926 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4926 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68788-6816 Levofloxacin Levofloxacin Preferred Pharamaceuticals, Inc. ANDA Current 68788-6816 Levofloxacin Levofloxacin Preferred Pharamaceuticals, Inc. ANDA Current 68788-6816 Levofloxacin Levofloxacin Preferred Pharamaceuticals, Inc. ANDA Current 68788-6816 Levofloxacin Levofloxacin Preferred Pharamaceuticals, Inc. ANDA Current 68788-6858 Levofloxacin Levofloxacin Preferred Pharmaceuticals Inc. ANDA Current 70518-0387 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-0387 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2145 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2145 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2145 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2145 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2145 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2249 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2249 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-2249 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70934-337 Levofloxacin Levofloxacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-337 Levofloxacin Levofloxacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-392 Levofloxacin Levofloxacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-392 Levofloxacin Levofloxacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-392 Levofloxacin Levofloxacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71205-234 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 71205-234 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 71205-234 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 71205-234 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 71335-0327 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0327 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0327 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0380 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0380 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0380 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-1208 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-1208 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-1208 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 76413-110 Levofloxacin Levofloxacin Central Texas Community Health Centers ANDA Current 80425-0009 Levaquin Levofloxacin 500mg Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0009 Levofloxacin Levofloxacin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0009 Levofloxacin Levofloxacin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0076 Levaquin Levofloxacin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0076 Levofloxacin Levofloxacin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current 80425-0076 Levofloxacin Levofloxacin Advanced Rx Pharmacy of Tennessee, LLC ANDA Current