Application 076622

Type: ANDA
Sponsor: BAUSCH AND LOMB

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
A076622-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2004-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076622-001	AT

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	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076622-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076622-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076622-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076622-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076622-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076622-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076622-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076622-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076622-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076622-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076622-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076622-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076622-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076622-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076622-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076622-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076622-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076622-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076622-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076622-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076622-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076622-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076622-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076622-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076622-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076622-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076622-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076622-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076622-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076622-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076622-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076622-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076622-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076622-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076622-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076622-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076622-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076622-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076622-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076622-001	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 1 · 7 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	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (product): 68788-7693
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (product): 24208-434
Ofloxacin	OFLOXACIN	A-S Medication Solutions	1838671d-e312-442a-b0bc-6702d6a8965c	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	af861f20-5ec8-2883-e053-2a95a90a2312	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (product): 68071-2265
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (product): 68071-2254
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ff88214e-19b5-428d-a10d-91c3edc89a66	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	Proficient Rx LP	c8020ad4-ac74-4ceb-863e-94da605cf23f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (product): 63187-268

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-439	Ofloxacin	Ofloxacin	Rebel Distributors Corp	ANDA	Current
24208-434	Ofloxacin	Ofloxacin	Bausch & Lomb Incorporated	ANDA	Current
24208-434	Ofloxacin	Ofloxacin	Bausch & Lomb Incorporated	ANDA	Current
24208-434	Ofloxacin	Ofloxacin	Bausch & Lomb Incorporated	ANDA	Current
24208-434	Ofloxacin	Ofloxacin	Bausch & Lomb Incorporated	ANDA	Current
24208-434	Ofloxacin	Ofloxacin	Bausch & Lomb Incorporated	ANDA	Current
50436-6112	Ofloxacin	Ofloxacin	Unit Dose Services	ANDA	Current
63187-268	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-268	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-268	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-268	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
68071-2254	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2254	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2265	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2265	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7693	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7693	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7693	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9204	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3573	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43091	ORIG	2012-03-28
8935	ORIG	2004-05-26