Application 076830

Type: ANDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OFLOXACIN	OFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.3%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076830-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			2004-08-31

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 · 42 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
2026-08-18 06:07:40	2026-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076830-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A076830-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076830-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076830-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076830-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076830-001	AT	1	`ea99ee380514…`

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 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 brand name: OFLOXACIN generic name: OFLOXACIN
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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0760	Ofloxacin	Ofloxacin	American Regent, Inc.	ANDA	Current