Application 021199

Type: NDA
Sponsor: SANTEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUIXIN	LEVOFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021199-001	QUIXIN	LEVOFLOXACIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2000-08-18

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021199-001	QUIXIN	0.5%	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021199-001	QUIXIN	0.5%	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`f41ea6bd6efb…`

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 4 of 4 · 77 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	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	631523e7-7d67-0cc3-e053-2a91aa0abb62	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Gland Pharma Limited	95479f18-76dc-41cf-a359-922febeed0f2	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Dr. Reddy's Laboratories Limited	9b59428a-a23a-b2d9-982f-98f8a1ed381f	2024-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Viona Pharmaceuticals Inc	0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Aurobindo Pharma Limited	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	ANI Pharmaceuticals, Inc.	a894e40b-77e4-439b-b0f8-9a5cc7a1dd90	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Eugia US LLC	4d400bf9-988f-42ec-93f1-e71a93a324b2	2024-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	72cb9372-e9f8-3ca1-e053-2a91aa0ad820	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Fresenius Kabi USA, LLC	eb30fafa-bbb9-458f-89df-ae610fa6aa96	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Asclemed USA, Inc.	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Macleods Pharmaceuticals Limited	fc165a6d-24b0-4753-a7ac-94a134dca0d3	2023-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	95149cfb-1a71-42b7-b50d-9a2e94334339	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	30958610-3803-45e6-aa3c-d256decbe6e4	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	e680c759-16c5-4532-9c9c-f42c8c3df74a	2019-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5	2019-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Baxter Healthcare Corporation	70c87464-1806-480a-8ebd-3f02987ff436	2019-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
14624	SUPPL	2014-12-10
4617	SUPPL	2014-12-04
36328	SUPPL	2005-04-12
27044	SUPPL	2005-04-12
14623	SUPPL	2005-04-12
4616	SUPPL	2005-04-12
42015	ORIG	2004-03-24
36327	SUPPL	2002-06-04
27043	SUPPL	2002-06-04
36326	SUPPL	2002-04-18
4615	SUPPL	2002-04-18
36325	ORIG	2000-08-18
4614	ORIG	2000-08-18