Application 207986

Type: NDA
Sponsor: OTONOMY INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OTIPRIO	CIPROFLOXACIN	INJECTABLE, SUSPENSION;OTIC	6% (60MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N207986-001	OTIPRIO	CIPROFLOXACIN	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC		RLD	2015-12-10

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207986-001	11369566	2029-04-21		Drug product	2022-07-14
N207986-001	9205048	2029-04-21	U-1793		2016-01-11
N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26
N207986-001	9233068	2029-12-11		Drug product	2016-02-05
N207986-001	8318817	2030-04-27	U-1792		2016-01-11
N207986-001	9220796	2035-07-01		Drug product	2016-01-11
N207986-001	11040004	2037-11-12	U-2252		2021-07-21
N207986-001	11246863	2038-11-27		Drug product	2022-03-11

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD, RS	2015-12-10	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 303 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207986-001	I-770	2021-03-02	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207986-001	I-770	2021-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207986-001	I-770	2021-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207986-001	I-770	2021-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207986-001	I-770	2021-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207986-001	I-770	2021-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207986-001	I-770	2021-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207986-001	I-770	2021-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207986-001	I-770	2021-03-02	`ea99ee380514…`

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 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	44b6cefc-7638-4437-95e7-8f239f66a9d4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	c08b37c3-5f01-47ed-9508-02813bbd008b	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	4deea61e-f3ca-b35d-e063-6294a90a9d41	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	HAWAII REPACK, INC	4caf49d9-b06f-4d57-aac3-cc64ae12cc95	2026-07-12	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	348e810c-e572-f3d2-e063-6394a90a0855	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	541bd97e-b2ff-09a8-e063-6394a90aee96	2026-06-13	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	5af16acc-51ce-41ed-b1c4-6b3fb38ef515	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a05035e1-f941-4f7c-9321-91dd50ab149b	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Cardinal Health 107, LLC	922e9f5c-cc59-4d9e-bf42-a4b900d077ed	2026-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals Inc.	18414c5a-8153-44f7-b27a-90c290af0a23	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	c2d8dcc9-23b0-75bb-e053-2995a90a02c8	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	3b9b15f7-354b-4049-982b-f6f31751a885	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	351b41db-622f-a1eb-e063-6294a90a5667	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf52e242-199b-4206-e053-2a95a90a1eb7	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	bf8d4359-a850-97b7-e053-2a95a90aa66a	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Major Pharmaceuticals	f818ed31-c746-4171-afdf-57a75434e5f1	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Cipro	CIPROFLOXACIN HYDROCHLORIDE	Bayer HealthCare Pharmaceuticals Inc.	888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Sportpharm LLC	190395a8-c05f-4e31-9a89-7af6428ebbb9	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	36d6c27d-45dc-3081-e063-6394a90a87e9	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0268-8200	OTIPRIO	OTIPRIO	ALK-Abello, Inc.	NDA	Current
0268-8200	OTIPRIO	OTIPRIO	ALK-Abello, Inc.	NDA	Current
69251-201	Otiprio	ciprofloxacin	Otonomy, Inc.	NDA	Current
69251-201	Otiprio	ciprofloxacin	Otonomy, Inc.	NDA	Current
69251-201	Otiprio	ciprofloxacin	Otonomy, Inc.	NDA	Current
69251-201	Otiprio	ciprofloxacin	Otonomy, Inc.	NDA	Current
69251-201	Otiprio	ciprofloxacin	Otonomy, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53009	SUPPL	2018-03-15
52820	SUPPL	2018-03-06
44968	ORIG	2016-02-19
43540	ORIG	2016-02-19
40607	SUPPL	2016-02-18
32873	SUPPL	2016-01-28
40606	ORIG	2015-12-15
10639	ORIG	2015-12-14
52576	ORIG	1900-01-01
52575	ORIG	1900-01-01
52574	ORIG	1900-01-01
52573	ORIG	1900-01-01