Application 218772

Type: NDA
Sponsor: SCIENTURE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARBLI	LOSARTAN POTASSIUM	SUSPENSION;ORAL	10MG/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
N218772-001	ARBLI	LOSARTAN POTASSIUM	10MG/ML	SUSPENSION / ORAL		RLD, RS	2025-03-13

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218772-001	11890273	2041-10-07		Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04
N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04
N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01
N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01

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.

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	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	ARBLI	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-03-13	`a50c72e98297…`

Observed Orange Book patent history#

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	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	11890273	2041-10-07		Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4158	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4159	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12156869	2041-10-07	U-4160	Drug product	2025-04-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12605365	2041-10-07	U-4159	Drug product	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218772-001	12605365	2041-10-07	U-4160	Drug product	2026-05-01	`a50c72e98297…`

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
ARBLI	LOSARTAN POTASSIUM	Scienture LLC	afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218772 application number: NDA218772

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
85134	SUPPL	2026-02-24
85077	SUPPL	2026-02-19
82161	ORIG	2025-05-06
81604	ORIG	2025-03-17
81601	ORIG	2025-03-17