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 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
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 · 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	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021721-001	LEVAQUIN	250MG/10ML	SOLUTION / ORAL	RLD	2004-10-21	`caaa826d4ba7…`
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…`

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 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
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