Application 076527

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;OTIC	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
A076527-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT		2007-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076527-001	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	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`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	A076527-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	a7952956-b64a-0f99-e053-2995a90a0f91	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 72189-108
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	REMEDYREPACK INC.	42366170-e536-46a1-9735-d76e5820a9de	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Apotex Corp.	8db221b1-32f3-f6ca-e404-71f56a860d08	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 60505-0363
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	76f461da-0e15-aa6d-e053-2a91aa0a9808	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 68071-1630
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	4f4048b2-3ae8-441a-b1e3-7311fac00f94	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	567fa672-5fd0-4a1d-bc12-054a9ac16117	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 63629-8716
Ofloxacin Otic	OFLOXACIN	A-S Medication Solutions	9d4b1225-e20d-4ace-850a-506fd031cac7	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 50090-1090
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	79ef87c3-1f09-1625-e053-2991aa0a84ae	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 68071-1588
Ofloxacin Otic	OFLOXACIN	Proficient Rx LP	14e6e355-3a87-43dc-80a2-070b9df93bf1	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 63187-184

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1090	Ofloxacin Otic	Ofloxacin	A-S Medication Solutions	ANDA	Current
50090-1090	Ofloxacin Otic	Ofloxacin	A-S Medication Solutions	ANDA	Current
50090-1090	Ofloxacin Otic	Ofloxacin	A-S Medication Solutions	ANDA	Current
53002-2604	Ofloxacin Otic	Ofloxacin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2604	Ofloxacin Otic	Ofloxacin	RPK Pharmaceuticals, Inc.	ANDA	Current
60505-0363	Ofloxacin Otic	Ofloxacin	Apotex Corp.	ANDA	Current
60505-0363	Ofloxacin Otic	Ofloxacin	Apotex Corp.	ANDA	Current
60505-0363	Ofloxacin Otic	Ofloxacin	Apotex Corp.	ANDA	Current
63187-184	Ofloxacin Otic	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-184	Ofloxacin Otic	Ofloxacin	Proficient Rx LP	ANDA	Current
63187-184	Ofloxacin Otic	Ofloxacin	Proficient Rx LP	ANDA	Current
63629-8716	Ofloxacin Otic	Ofloxacin	Bryant Ranch Prepack	ANDA	Current
63629-8716	Ofloxacin Otic	Ofloxacin	Bryant Ranch Prepack	ANDA	Current
68071-1588	Ofloxacin Otic	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1588	Ofloxacin Otic	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1588	Ofloxacin Otic	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1630	Ofloxacin Otic	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1630	Ofloxacin Otic	Ofloxacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9504	Ofloxacin Otic	Ofloxacin	Preferred Pharmaceuticals, Inc.	ANDA	Current
72189-108	OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	ANDA	Current
72189-108	OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43086	ORIG	2011-09-16