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 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
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 · 43 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	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`84e616aacf4f…`
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…`

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 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFLOXACIN	OFLOXACIN	Redpharm Drug	37456656-77c8-d74c-e063-6294a90ab729	2025-12-13	Warnings, Adverse reactions	Name fallback brand name: OFLOXACIN generic name: OFLOXACIN
Ofloxacin	OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%	SOLA Pharmaceuticals, LLC	4ca27244-ed70-4868-b2d8-8f97c3a52148	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin
Ofloxacin	OFLOXACIN	Redpharm Drug	3dd035d0-c3ec-3fc2-e063-6294a90a4aac	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	NuCare Pharmaceuticals, Inc.	4484283c-7839-e75d-e063-6394a90a8639	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	A-S Medication Solutions	8fd1eba2-2ed2-40a8-ae10-957b07434fe5	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ab5b0e34-ac5c-4c0c-b104-934b319ae011	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%	Caplin Steriles Limited	53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b	2025-02-05	Warnings, Adverse reactions	Name fallback brand 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 brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	Lifestar Pharma LLC	871d63f4-41c1-4b30-903c-11fbf0d4c1f8	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN OTIC	Caplin Steriles Limited	2bb61a24-87a6-4e74-a319-fc5e7c483bbb	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin
ofloxacin	OFLOXACIN	Major Pharmaceuticals	2d7a1f80-1c59-49e6-aff7-aedacade2dd6	2024-11-12	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Somerset Therapeutics, LLC	72ad7b86-1d5b-48c9-bb40-319d6c186f1d	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	1838671d-e312-442a-b0bc-6702d6a8965c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Somerset Therapeutics, LLC	4b2b893d-c19b-4c4a-85de-ff901325080b	2024-10-11	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin 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 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 · 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