Application 078559

Type: ANDA
Sponsor: FDC LTD

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
A078559-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078559-001	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	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`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	A078559-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	A-S Medication Solutions	537c6351-c7f1-47c9-95de-011bac850768	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559 ndc (product): 50090-5425
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	c76d8dc7-9a66-471b-814b-ef7f3605ec93	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559 ndc (product): 64980-515
Ofloxacin	OFLOXACIN	Proficient Rx LP	a2089612-de4b-4d78-b311-fa2524bd37f6	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559 ndc (product): 63187-734

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5425	Ofloxacin	Ofloxacin	A-S Medication Solutions	ANDA	Current
52959-763	ofloxacin	ofloxacin	H.J. Harkins Company, Inc.	ANDA	Current
55545-1003	Ofloxacin	Ofloxacin	FDC Limited	ANDA	Current
63187-734	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-734	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-734	Ofloxacin	Ofloxacin	Proficient Rx LP	ANDA	Current
64980-515	Ofloxacin	Ofloxacin	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-515	Ofloxacin	Ofloxacin	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-515	Ofloxacin	Ofloxacin	Rising Pharmaceuticals, Inc.	ANDA	Current
68071-4832	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4832	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5150	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5150	Ofloxacin	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8264	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8993	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8993	Ofloxacin	Ofloxacin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1892	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1892	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1892	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1892	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1892	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-2037	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-2037	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-2037	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-2037	Ofloxacin	Ofloxacin	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44632	ORIG	2009-03-03