Home Applications 076890 Application 076890
Type ANDA
Sponsor CIPLA 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 A076890-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 A076890-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 A076890-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30
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 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 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 1 of 1 · 52 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-2963 Levofloxacin Levofloxacin A-S Medication Solutions ANDA Current 50090-2967 Levofloxacin Levofloxacin A-S Medication Solutions ANDA Current 50090-3013 Levofloxacin Levofloxacin A-S Medication Solutions ANDA Current 53217-318 Levofloxacin Levofloxacin Aidarex Pharmaceuticals LLC ANDA Current 55700-454 Levofloxacin Levofloxacin Lake Erie Medical DBA Quality Care Products LLC ANDA Current 61919-440 LEVOFLOXACIN LEVOFLOXACIN DIRECT RX ANDA Current 61919-440 LEVOFLOXACIN LEVOFLOXACIN DIRECT RX ANDA Current 61919-440 LEVOFLOXACIN LEVOFLOXACIN DIRECT RX ANDA Current 63187-384 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-384 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-384 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-925 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63187-925 Levofloxacin Levofloxacin Proficient Rx LP ANDA Current 63629-7681 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 63629-7681 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 67296-1351 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-1351 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-1351 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-1535 Levofloxacin Levofloxacin RedPharm Drug ANDA Current 67296-1535 Levofloxacin Levofloxacin RedPharm Drug ANDA Current 67296-1535 Levofloxacin Levofloxacin RedPharm Drug ANDA Current 67296-1546 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-1546 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 67296-1546 Levofloxacin Levofloxacin RedPharm Drug, Inc. ANDA Current 68071-3089 Levofloxacin Levofloxacin NuCare Pharmaceuticals, Inc. ANDA Current 68071-3091 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-3271 Levofloxacin Levofloxacin NuCare Pharmaceuticals ,Inc. ANDA Current 68071-4101 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4340 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 68071-4623 Levofloxacin Levofloxacin NuCare Pharmaceuticals,Inc. ANDA Current 69097-282 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-282 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-282 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-282 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-287 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-287 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-287 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-287 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-287 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-289 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-289 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-289 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 69097-289 Levofloxacin Levofloxacin Cipla USA Inc. ANDA Current 70518-0709 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-0709 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-1135 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 70518-1135 Levofloxacin Levofloxacin REMEDYREPACK INC. ANDA Current 71335-0133 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0391 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0391 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0391 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current 71335-0525 Levofloxacin Levofloxacin Bryant Ranch Prepack ANDA Current