Application 021721

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVAQUIN	LEVOFLOXACIN	SOLUTION;ORAL	250MG/10ML	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
N021721-001	LEVAQUIN	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL		RLD	2004-10-21

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	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021721-001	6806256	2022-02-26	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021721-001	6806256	2022-02-26	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021721-001	6806256	2022-02-26	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021721-001	6806256	2022-02-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021721-001	6806256	2022-02-26	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021721-001	6806256	2022-02-26	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021721-001	6806256	2022-02-26	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021721-001	6806256	2022-02-26	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021721-001	6806256	2022-02-26	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021721-001	6806256	2022-02-26	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021721-001	6806256	2022-02-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021721-001	6806256	2022-02-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021721-001	6806256	2022-02-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021721-001	6806256	2022-02-26	Drug product	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021721-001	6806256	2022-02-26	Drug product	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021721-001	6806256	2022-02-26	Drug product	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021721-001	6806256	2022-02-26	Drug product	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021721-001	6806256	2022-02-26	Drug product	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021721-001	6806256*PED	2022-08-26	Pediatric extension	`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 · 76 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
47161	SUPPL	2017-02-10
47151	SUPPL	2017-02-09
37534	SUPPL	2016-07-26
6057	SUPPL	2016-07-26
24212	SUPPL	2015-03-10
21790	SUPPL	2015-03-10
37533	SUPPL	2014-05-28
28470	SUPPL	2014-05-28
6056	SUPPL	2013-08-16
37532	SUPPL	2013-08-15
42284	SUPPL	2012-06-22
21791	SUPPL	2012-06-22
28467	SUPPL	2012-05-01
37530	SUPPL	2012-04-30
28469	SUPPL	2011-10-13
28468	SUPPL	2011-10-13
37531	SUPPL	2011-10-12
16261	SUPPL	2011-10-12
37529	SUPPL	2011-06-14
28466	SUPPL	2011-06-14
37528	SUPPL	2011-03-04
6055	SUPPL	2011-03-03
43772	ORIG	2009-11-19
37527	SUPPL	2009-05-11
6054	SUPPL	2009-05-05
28465	SUPPL	2009-03-13
37526	SUPPL	2008-10-08
28464	SUPPL	2008-10-07
24211	SUPPL	2008-07-16
16260	SUPPL	2008-06-05
28461	SUPPL	2008-05-08
28463	SUPPL	2008-04-18
28462	SUPPL	2008-01-09
37525	SUPPL	2007-12-14
37524	SUPPL	2007-11-19
16259	SUPPL	2007-11-19
6053	SUPPL	2007-11-19
6052	SUPPL	2007-11-19
28460	SUPPL	2007-09-25
28459	SUPPL	2007-09-25
37521	SUPPL	2007-09-19
16258	SUPPL	2007-09-19
6051	SUPPL	2007-07-05
37523	SUPPL	2007-06-27
16257	SUPPL	2007-06-04
6049	SUPPL	2007-06-04
37522	SUPPL	2007-05-16
6050	SUPPL	2007-05-16
21789	ORIG	2007-04-20
37520	SUPPL	2006-06-28
6048	SUPPL	2006-06-28
28458	SUPPL	2006-01-30
37519	SUPPL	2006-01-27
37517	SUPPL	2005-08-08
28457	SUPPL	2005-08-08
37518	SUPPL	2004-12-03
6047	SUPPL	2004-12-02
16256	ORIG	2004-11-01
6046	ORIG	2004-10-29
52018	SUPPL	1900-01-01
52013	SUPPL	1900-01-01
52012	SUPPL	1900-01-01
52006	SUPPL	1900-01-01
52005	SUPPL	1900-01-01