Application 076615

Type: ANDA
Sponsor: HI TECH PHARMA

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 1.

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
A076615-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			2004-05-14

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076615-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076615-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076615-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076615-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076615-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076615-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076615-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076615-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076615-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076615-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076615-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076615-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076615-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076615-001	AT	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A076615-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076615-001	AT	1	`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 1 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals, Inc.	0c01de7a-a885-4bf0-8df0-7c62170b7850	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	306ed758-3c43-4f42-bd44-562ec65891dc	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	Sportpharm LLC	3f5972db-4eaf-4237-944d-8f63eff7b9b1	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	St. Mary's Medical Park Pharmacy	2d55b26d-9d12-ca29-e063-6294a90ab237	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	REMEDYREPACK INC.	fe619d50-49bf-4fcc-9428-6108c45580eb	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
OFLOXACIN	OFLOXACIN	Modavar Pharmaceuticals LLC	93ed9f70-b44f-496b-bdfc-c1bd5f1c260b	2026-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OFLOXACIN generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	REMEDYREPACK INC.	d97651cc-d9ea-4be4-8ea1-3d0278582dd5	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	a7952956-b64a-0f99-e053-2995a90a0f91	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	5f4213e4-de32-4c03-8800-e254b98538ea	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	537c6351-c7f1-47c9-95de-011bac850768	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	f7916bb3-7593-45f8-b9de-98e0f2d57227	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	2e912ed6-51e8-40c3-bf10-2af092c63be8	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Redpharm Drug	2fbd51a5-462c-4741-e063-6394a90a0d87	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
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

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
50383-024	Ofloxacin	Ofloxacin	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-024	Ofloxacin	Ofloxacin	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-024	Ofloxacin	Ofloxacin	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-024	Ofloxacin	Ofloxacin	Akorn	ANDA	Current
68387-106	Ofloxacin	Ofloxacin	Keltman Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8933	ORIG	2004-05-26