Application 076093

Type: ANDA
Sponsor: LARKEN LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OFLOXACIN	OFLOXACIN	TABLET;ORAL	200MG	No	No
002	OFLOXACIN	OFLOXACIN	TABLET;ORAL	300MG	No	No
003	OFLOXACIN	OFLOXACIN	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	Approval date
A076093-001	OFLOXACIN	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02
A076093-002	OFLOXACIN	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02
A076093-003	OFLOXACIN	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076093-003	AB

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076093-002	OFLOXACIN	300MG	TABLET / ORAL		2003-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076093-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2003-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076093-001	OFLOXACIN	200MG	TABLET / ORAL		2003-09-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076093-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076093-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076093-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076093-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076093-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076093-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076093-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076093-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076093-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076093-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076093-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076093-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076093-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076093-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076093-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076093-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076093-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076093-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076093-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A076093-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076093-003	AB	1	`782e0a99824c…`
2019-09-15 20:21 UTC	2019-09	A076093-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076093-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076093-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076093-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076093-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076093-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076093-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076093-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076093-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076093-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076093-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076093-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076093-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076093-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076093-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076093-003	AB	1	`a50c72e98297…`

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 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ofloxacin	OFLOXACIN	NorthStar RxLLC	7c98c671-aefa-48c3-971a-001f16aa72a8	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	A-S Medication Solutions	71949588-42e2-446c-b7ec-904c09b2f95f	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ff9776b3-a244-e1ea-e053-6294a90aeb7b	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	NuCare Pharmaceuticals,Inc.	1e917318-cdc7-cd2c-e063-6294a90a0cc2	2024-08-02	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	Proficient Rx LP	5a9de529-6f85-467a-97b0-8ce124c31173	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin 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 OTIC	Amneal Pharmaceuticals NY LLC	ba37e2a0-1bf7-41ca-bddd-35fcb77f87de	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	af861f20-5ec8-2883-e053-2a95a90a2312	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin 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 brand name: OFLOXACIN generic name: OFLOXACIN
OCUFLOX	OFLOXACIN	Allergan, Inc.	7aab4449-3dda-4e2c-8e40-b3244a548bf5	2024-06-13	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	Asclemed USA, Inc.	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
ofloxacin	OFLOXACIN	Proficient Rx LP	0c4e0b81-a344-4678-97d2-b15dc2857882	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	392d458f-8815-49f4-9c2b-0e721e295b1f	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
OFLOXACIN	OFLOXACIN	Leading Pharma, LLC	e43bf505-1030-49cd-a144-19b997fb5575	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: OFLOXACIN generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	Proficient Rx LP	79074efc-83ed-4473-bb86-9f635928ea92	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	NuCare Pharmceuticals,Inc.	102c825b-af5c-42e7-e063-6394a90a81a1	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN OTIC	A-S Medication Solutions	d89fa470-c98b-433a-829b-abe97eb66419	2024-01-21	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin
ofloxacin	OFLOXACIN	A-S Medication Solutions	48dc8354-9a36-427b-ade9-818db6bfb01b	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68047-713	ofloxacin	ofloxacin	Larken Laboratories, Inc.	ANDA	Current
68047-713	ofloxacin	ofloxacin	Larken Laboratories, Inc.	ANDA	Current
68047-713	ofloxacin	ofloxacin	Larken Laboratories, Inc.	ANDA	Current
68047-713	ofloxacin	ofloxacin	Larken Laboratories, Inc.	ANDA	Current
68047-713	ofloxacin	ofloxacin	Larken Laboratories, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31074	ORIG	2003-04-16