Home Applications 091678 Application 091678
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVOFLOXACIN LEVOFLOXACIN SOLUTION;ORAL 250MG/10ML No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091678-001 LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091678-001 AA
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 2 · 42 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 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levofloxacin LEVOFLOXACIN ANI Pharmaceuticals, Inc. a894e40b-77e4-439b-b0f8-9a5cc7a1dd90 2024-06-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091678 application number: ANDA091678
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0286 Levofloxacin Levofloxacin ATLANTIC BIOLOGICALS CORP. ANDA Current 50383-286 Levofloxacin Levofloxacin Akorn ANDA Current 50383-286 Levofloxacin Levofloxacin Akorn ANDA Current 50383-286 Levofloxacin Levofloxacin Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-286 Levofloxacin Levofloxacin Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-286 Levofloxacin Levofloxacin Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-286 Levofloxacin Levofloxacin Akorn ANDA Current 55695-007 Levofloxacin Levofloxacin Department of State Health Services, Pharmacy Branch ANDA Current