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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	36d6c27d-45dc-3081-e063-6394a90a87e9	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals, Inc.	85c48ebc-d94a-4254-86df-d2c1aff09b37	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f6debb60-d885-230b-e053-6394a90ad73a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	f67d727f-b9ca-aec0-e053-2995a90aab69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	QPharma Inc	4d5afeff-3917-43e1-9d12-d70ccab00dcc	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Chartwell RX, LLC	905503ef-4277-44ca-aa4a-5a969a041e16	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin in Dextrose	CIPROFLOXACIN	ProPharma Distribution	42c758be-4d44-018a-e063-6294a90ae041	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin in Dextrose	CIPROFLOXACIN	Hospira, Inc.	cbbbf939-3219-4515-a48e-ca264daa4d07	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Method Pharmaceuticals, LLC	acb03e72-ce94-58c5-e053-2a95a90a683a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	QPharma, Inc.	4149d980-a6cd-c06d-e063-6394a90a47a1	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Rising Pharma Holdings, Inc.	ef468722-68cd-440b-afd7-2285029db41f	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	2491e6a9-3415-43b9-b31b-67331f52806a	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	e81341c6-0e25-4860-adda-2d3cebe88d62	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	178dc379-e2b8-4b47-9f0c-3fc7fb435c36	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	c12b316f-811c-48b6-a320-d314991aa74f	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	69df48cc-76b6-428e-891a-c25e07d785f8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a5ecc693-b8fd-4a7a-8040-e56f801c9353	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Advanced Rx of Tennessee, LLC	30cb2b42-aa4b-8cec-e063-6394a90aa615	2025-03-20	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Coupler LLC	2fff7a38-2c4e-d343-e063-6294a90aca3c	2025-03-10	Boxed warning, 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