Application 019735

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOXIN	OFLOXACIN	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	FLOXIN	OFLOXACIN	TABLET;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	FLOXIN	OFLOXACIN	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019735-001	FLOXIN	OFLOXACIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28
N019735-002	FLOXIN	OFLOXACIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28
N019735-003	FLOXIN	OFLOXACIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019735-002	FLOXIN	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019735-003	FLOXIN	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019735-001	FLOXIN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1990-12-28	`79d66fd596c7…`

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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ab5b0e34-ac5c-4c0c-b104-934b319ae011	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	76f461da-0e15-aa6d-e053-2a91aa0a9808	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals, Inc.	51f3d155-36df-4c40-e054-00144ff8d46c	2024-12-24	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN	Lifestar Pharma LLC	871d63f4-41c1-4b30-903c-11fbf0d4c1f8	2024-12-23	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN	Major Pharmaceuticals	2d7a1f80-1c59-49e6-aff7-aedacade2dd6	2024-11-12	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Somerset Therapeutics, LLC	72ad7b86-1d5b-48c9-bb40-319d6c186f1d	2024-10-31	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	1838671d-e312-442a-b0bc-6702d6a8965c	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Somerset Therapeutics, LLC	4b2b893d-c19b-4c4a-85de-ff901325080b	2024-10-11	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	4f4048b2-3ae8-441a-b1e3-7311fac00f94	2024-09-20	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	567fa672-5fd0-4a1d-bc12-054a9ac16117	2024-09-19	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
OFLOXACIN	OFLOXACIN	Cadila Pharmaceuticals Limited	c677b35c-0432-4ee5-af57-1f95449c48b6	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN	NorthStar RxLLC	7c98c671-aefa-48c3-971a-001f16aa72a8	2024-08-29	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ff9776b3-a244-e1ea-e053-6294a90aeb7b	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Proficient Rx LP	5a9de529-6f85-467a-97b0-8ce124c31173	2024-08-01	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	A-S Medication Solutions	9d4b1225-e20d-4ace-850a-506fd031cac7	2024-07-18	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	af861f20-5ec8-2883-e053-2a95a90a2312	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	79ef87c3-1f09-1625-e053-2991aa0a84ae	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
OFLOXACIN	OFLOXACIN	Leading Pharma, LLC	7552729e-a41e-4eb1-8b37-b48a86112790	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN

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
43624	SUPPL	2011-03-04
33903	SUPPL	2011-03-04
1565	SUPPL	2011-03-03
40992	SUPPL	2009-09-16
20312	SUPPL	2009-09-16
1564	SUPPL	2009-02-13
33902	SUPPL	2008-10-09
1563	SUPPL	2008-10-07
40991	SUPPL	2008-04-04
40990	SUPPL	2008-04-04
20311	SUPPL	2008-04-04
20310	SUPPL	2008-04-04
1562	SUPPL	2008-01-09
33901	SUPPL	2007-12-14
19138	SUPPL	2007-07-05
33900	SUPPL	2007-06-27
11667	SUPPL	2007-05-29
1561	SUPPL	2007-05-29
33899	SUPPL	2006-06-20
1560	SUPPL	2006-06-20
40989	SUPPL	2006-05-10
40988	SUPPL	2006-05-10
20309	SUPPL	2006-05-10
20308	SUPPL	2006-05-10
20307	SUPPL	2006-05-10
19137	SUPPL	2006-01-30
11666	SUPPL	2006-01-27
33898	SUPPL	2004-09-17
33897	SUPPL	2004-09-17
19136	SUPPL	2004-09-17
19135	SUPPL	2004-09-17
33896	SUPPL	2004-04-05
19134	SUPPL	2004-03-10