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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207986-001	OTIPRIO	6% (60MG/ML)	INJECTABLE, SUSPENSION / OTIC	RLD	2015-12-10	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 311 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207986-001	11369566	2029-04-21		Drug product	2022-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	9205048	2029-04-21	U-1793		2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	9603796	2029-04-21	U-2252	Drug substance, Drug product	2018-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	9233068	2029-12-11		Drug product	2016-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	8318817	2030-04-27	U-1792		2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	9220796	2035-07-01		Drug product	2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	11040004	2037-11-12	U-2252		2021-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207986-001	11246863	2038-11-27		Drug product	2022-03-11	`84e616aacf4f…`
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…`

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 3 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin	CIPROFLOXACIN	Umasuto, LLC	0c355077-7361-41d0-9e82-eb31beaf5daa	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	2efbda2a-fc97-b7c5-e063-6294a90a362d	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	fa32aafd-e3f5-4be6-9413-c7663c1c2cec	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	5723eaf9-8659-4730-b792-4e4c33690ccb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d275175c-691a-4d09-bbb7-50ee819e6727	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	17435f05-f04d-e792-e063-6294a90af145	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
CIPROFLOXACIN	CIPROFLOXACIN	Direct Rx	d88a22f4-2f61-17f2-e053-2995a90acd14	2025-01-21	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
CIPROFLOXACIN	CIPROFLOXACIN	DirectRx	d23e359d-6d12-38f6-e053-2a95a90a0a88	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	DirectRx	d358eb18-f4d0-e9ba-e053-2a95a90a435d	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Golden State Medical Supply, Inc.	2e1addcf-6d5b-46c8-812b-558fd847f005	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Hikma Pharmaceuticals USA Inc.	3b3d22dc-df09-4910-8c9b-1204eeedbd68	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Teva Pharmaceuticals USA, Inc.	3e4402d4-e0d3-9846-3e81-ed46f34137fe	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Amneal Pharmaceuticals NY LLC	b996e81b-36ec-4ad7-a7c4-bc6700a06648	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	2024-10-01	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	44e5582d-fff1-0ec9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	46dedf2c-26de-0f46-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b0136d72-0869-2da0-e053-2995a90af70a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b064286b-fedc-be68-e053-2995a90aae52	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7def5a45-6725-0521-e053-2991aa0a0bda	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7d533171-0879-3854-e053-2a91aa0a3b46	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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