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QUIXIN	LEVOFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N021199-001	QUIXIN	LEVOFLOXACIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2000-08-18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N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`caaa826d4ba7…`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UTC	2026-02	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`011fe1cb6892…`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of this ZIP	2025-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`31067a03dcf5…`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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	05d179f5-b200-8597-e063-6394a90a10cc	2025-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	80501b71-2f08-2ef5-e053-2991aa0a6e86	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Coupler LLC	2cee61b7-be51-0fe5-e063-6294a90af9e3	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc	067e260c-dc47-4957-a9ff-5a79f17b4ca0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	DirectRx	dabedb15-5b55-3853-e053-2995a90aa44e	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d98cf024-51fa-45a1-b247-da55aba88ca0	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	8423b021-e09c-4f1c-e053-2991aa0afef6	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	A-S Medication Solutions	bdc8b2cc-a914-4613-ac7c-e8dfe91dea13	2024-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	171ab6c6-8eb5-4716-926f-cee52b7d0968	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	Gland Pharma Limited	ba69722b-d7f2-4519-8a63-9ee91294c499	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	54a02488-586d-4c4e-8a35-68a067bdd6e3	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b7a614b0-f604-48e1-9919-21da8f939d93	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	804ec547-5b89-4fd0-89b3-7445543e563e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Camber Pharmaceuticals, Inc.	b43e9b51-568c-4d84-bbd1-d237120056c4	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals, Inc.	4a405103-41e8-6a1f-e054-00144ff8d46c	2024-07-19	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