Application 078424

Type: ANDA
Sponsor: LUPIN

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	Approval date
A078424-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A078424-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A078424-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078424-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078424-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078424-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078424-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078424-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078424-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078424-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078424-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078424-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078424-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078424-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078424-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078424-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078424-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078424-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078424-001	AB	1	`8072bd15b7f6…`

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	Lupin Pharmaceuticals, Inc.	4be13bd5-0c39-43c3-9232-b1226ccd4dbc	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078424 application number: ANDA078424 ndc (product): 68180-240 ndc (product): 68180-241 ndc (product): 68180-242

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-434	Levofloxacin	Levofloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68084-481	Levofloxacin	Levofloxacin	American Health Packaging	ANDA	Current
68084-482	Levofloxacin	Levofloxacin	American Health Packaging	ANDA	Current
68084-483	Levofloxacin	Levofloxacin	American Health Packaging	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, In	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-240	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, In	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-241	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, In	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-242	Levofloxacin	Levofloxacin	Lupin Pharmaceuticals, Inc.	ANDA	Current