Application 090367

Type: ANDA
Sponsor: CELLTRION

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
A090367-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A090367-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A090367-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090367-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090367-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090367-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090367-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090367-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090367-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090367-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090367-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090367-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090367-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090367-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090367-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090367-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090367-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090367-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090367-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090367-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090367-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090367-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090367-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090367-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090367-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090367-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090367-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090367-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090367-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090367-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090367-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090367-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090367-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090367-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090367-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090367-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090367-001	AB	1	`6a51e52b5d6a…`

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 3 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levofloxacin	LEVOFLOXACIN	Coupler LLC	2cee61b7-be51-0fe5-e063-6294a90af9e3	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc	067e260c-dc47-4957-a9ff-5a79f17b4ca0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	DirectRx	dabedb15-5b55-3853-e053-2995a90aa44e	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d98cf024-51fa-45a1-b247-da55aba88ca0	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	8423b021-e09c-4f1c-e053-2991aa0afef6	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4b7333-4f77-4ec9-e053-2a95a90a16d2	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	b001d60e-b8fb-54ff-e053-2a95a90a2970	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	WG Critical Care, LLC	9020cdeb-65fe-458f-bbbd-69265a49906e	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	A-S Medication Solutions	bdc8b2cc-a914-4613-ac7c-e8dfe91dea13	2024-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Golden State Medical Supply, Inc.	bfe280be-0789-69fa-e053-2a95a90a0e13	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	171ab6c6-8eb5-4716-926f-cee52b7d0968	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	Gland Pharma Limited	ba69722b-d7f2-4519-8a63-9ee91294c499	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOFLOXACIN generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	54a02488-586d-4c4e-8a35-68a067bdd6e3	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b7a614b0-f604-48e1-9919-21da8f939d93	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	804ec547-5b89-4fd0-89b3-7445543e563e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Camber Pharmaceuticals, Inc.	b43e9b51-568c-4d84-bbd1-d237120056c4	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals, Inc.	4a405103-41e8-6a1f-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Lupin Pharmaceuticals, Inc.	4be13bd5-0c39-43c3-9232-b1226ccd4dbc	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-793	Levofloxacin	Levofloxacin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-876	Levofloxacin	Levofloxacin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-891	Levofloxacin	Levofloxacin	Aidarex Pharmaceuticals LLC	ANDA	Current
55648-544	Levofloxacin	Levofloxacin	Wockhardt Limited	ANDA	Current
55648-545	Levofloxacin	Levofloxacin	Wockhardt Limited	ANDA	Current
55648-547	Levofloxacin	Levofloxacin	Wockhardt Limited	ANDA	Current
64679-544	Levofloxacin	Levofloxacin	Wockhardt USA LLC.	ANDA	Current
64679-545	Levofloxacin	Levofloxacin	Wockhardt USA LLC.	ANDA	Current
64679-547	Levofloxacin	Levofloxacin	Wockhardt USA LLC.	ANDA	Current
68788-9709	Levofloxacin	Levofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current