Application 076513

Type: ANDA
Sponsor: APOTEX INC

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
A076513-001	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
A076513-001	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	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076513-001	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	A076513-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076513-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076513-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076513-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076513-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076513-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076513-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076513-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076513-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076513-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076513-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076513-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076513-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076513-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076513-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076513-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076513-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076513-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076513-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076513-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076513-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076513-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076513-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076513-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076513-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076513-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076513-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076513-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076513-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076513-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076513-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076513-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076513-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076513-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076513-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076513-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076513-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076513-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076513-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076513-001	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	St. Mary's Medical Park Pharmacy	2d55b26d-9d12-ca29-e063-6294a90ab237	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	f7916bb3-7593-45f8-b9de-98e0f2d57227	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	Apotex Corp.	5117d567-2004-c5ed-1391-f8831864696f	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513 ndc (product): 60505-0560
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ab5b0e34-ac5c-4c0c-b104-934b319ae011	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513 ndc (product): 50090-5209
Ofloxacin	OFLOXACIN	Proficient Rx LP	5a9de529-6f85-467a-97b0-8ce124c31173	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513 ndc (product): 71205-420
Ofloxacin	OFLOXACIN	A-S Medication Solutions	392d458f-8815-49f4-9c2b-0e721e295b1f	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513 ndc (product): 50090-5186
Ofloxacin	OFLOXACIN	NuCare Pharmceuticals,Inc.	102c825b-af5c-42e7-e063-6394a90a81a1	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5186	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5186	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5186	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5209	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5209	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5209	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
50090-5210	Ofloxacin	ofloxacin	A-S Medication Solutions	ANDA	Current
60505-0560	Ofloxacin	ofloxacin	Apotex Corp.	ANDA	Current
60505-0560	Ofloxacin	ofloxacin	Apotex Corp.	ANDA	Current
60505-0560	Ofloxacin	ofloxacin	Apotex Corp.	ANDA	Current
68071-2544	Ofloxacin	ofloxacin	NuCare Pharmaceuticaals,Inc.	ANDA	Current
68788-8178	Ofloxacin	ofloxacin	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-420	Ofloxacin	ofloxacin	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31134	ORIG	2004-05-26