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QUIXIN	LEVOFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 1.

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N021199-001	QUIXIN	LEVOFLOXACIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2000-08-18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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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UTC	2026-02	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`011fe1cb6892…`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of this ZIP	2025-12	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`31067a03dcf5…`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UTC	2025-08	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`6a471c1ec25d…`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of this ZIP	2025-03	N021199-001	QUIXIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2000-08-18	`fd3edfee7708…`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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Sagent Pharmaceuticals	699fbdb8-a6fd-476a-9b80-08197d869534	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	2a4e97e0-0709-411b-92e8-6f7d669412e4	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	710c0c10-89a5-4954-8f74-acc187c5cf0f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Chartwell RX, LLC	5c6c117c-9d91-48f4-9aaa-ee70b99218c2	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	f14cf651-a213-4a4f-adb9-f628562af27c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	5261da15-1b6c-fbe2-e063-6394a90ad85e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Cardinal Health 107, LLC	070375be-3b67-4299-ae8f-4a7b157ac16f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	bcad1dad-53aa-43dd-90f3-cc17cc9598d5	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	2a8676a9-247f-4fdb-b644-e9785d98771f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	DIRECT RX	4f40d5fa-ebcc-516c-e054-00144ff8d46c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	44f31105-5fc9-43d4-e063-6294a90a510f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	264a3f71-f23e-45e3-926a-421bcccf4e3d	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc.	7a12135e-cbad-4fe1-98f7-53c41d1f2a21	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	b8ac5047-5203-42c4-886b-dd0b08a1786f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	16d51c1c-4144-4be7-9356-98fcee621ecd	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f2f090c2-3ee1-7689-e053-2995a90abe38	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f780bb91-483a-d1a6-e053-6294a90ab74b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOFLOXACIN

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