Application 206307

Type: NDA
Sponsor: MERLION PHARMS GMBH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XTORO	FINAFLOXACIN	SUSPENSION/DROPS;OTIC	0.3%	Yes	No

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
N206307-001	XTORO	FINAFLOXACIN	0.3%	SUSPENSION/DROPS / OTIC		RLD, RS	2014-12-17

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206307-001	9119859	2030-07-02	U-1679		2015-09-15
N206307-001	9993483	2030-07-02		Drug product	2022-03-28
N206307-001	8536167	2031-08-08	U-1679		2015-04-10
N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16

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	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD, RS	2014-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD, RS	2014-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206307-001	XTORO	0.3%	SUSPENSION/DROPS / OTIC	RLD	2014-12-17	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 161 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	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206307-001	9119859	2030-07-02	U-1679		2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206307-001	9993483	2030-07-02		Drug product	2022-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206307-001	8536167	2031-08-08	U-1679		2015-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206307-001	9504691	2033-11-21	U-1679	Drug product	2016-12-16	`5bbf6a4d5a75…`

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	N206307-001	NCE	2019-12-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206307-001	PED	2020-06-17	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206307-001	PED	2020-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206307-001	PED	2020-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206307-001	NCE	2019-12-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206307-001	PED	2020-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206307-001	NCE	2019-12-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206307-001	PED	2020-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206307-001	NCE	2019-12-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206307-001	PED	2020-06-17	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XTORO	FINAFLOXACIN	Fonseca Biosciences, LLC	5c628272-019e-4511-8d5c-dcf56023da25	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206307 application number: NDA206307

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85488	SUPPL	2026-03-24
85423	SUPPL	2026-03-20
85422	SUPPL	2026-03-20
44941	ORIG	2015-01-14
43513	ORIG	2015-01-14
19713	ORIG	2014-12-19
10556	ORIG	2014-12-19
63919	ORIG	1900-01-01
51108	ORIG	1900-01-01
51107	ORIG	1900-01-01
51106	ORIG	1900-01-01