Application 218879

Type: NDA
Sponsor: OWP PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUBVENITE	LAMOTRIGINE	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
N218879-001	SUBVENITE	LAMOTRIGINE	10MG/ML	SUSPENSION / ORAL		RLD, RS	2025-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218879-001	11596634	2040-05-29	U-4271		2025-09-26
N218879-001	11596634	2040-05-29	U-4272		2025-09-26
N218879-001	11596634	2040-05-29	U-4273		2025-09-26
N218879-001	11612566	2040-05-29	U-4271		2025-09-26
N218879-001	11612566	2040-05-29	U-4272		2025-09-26
N218879-001	11612566	2040-05-29	U-4273		2025-09-26
N218879-001	12629377	2040-05-29	U-4539	Drug product	2026-06-18
N218879-001	12629377	2040-05-29	U-4540	Drug product	2026-06-18
N218879-001	12629377	2040-05-29	U-4541	Drug product	2026-06-18
N218879-001	12636289	2040-05-29		Drug product	2026-06-18

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	N218879-001	SUBVENITE	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218879-001	SUBVENITE	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218879-001	SUBVENITE	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	SUBVENITE	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-09-16	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	SUBVENITE	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-09-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 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	N218879-001	11596634	2040-05-29	U-4271		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	11596634	2040-05-29	U-4272		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	11596634	2040-05-29	U-4273		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	11612566	2040-05-29	U-4271		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	11612566	2040-05-29	U-4272		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	11612566	2040-05-29	U-4273		2025-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	12629377	2040-05-29	U-4539	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	12629377	2040-05-29	U-4540	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	12629377	2040-05-29	U-4541	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218879-001	12636289	2040-05-29		Drug product	2026-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218879-001	11596634	2040-05-29	U-4271		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	11596634	2040-05-29	U-4272		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	11596634	2040-05-29	U-4273		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	11612566	2040-05-29	U-4271		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	11612566	2040-05-29	U-4272		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	11612566	2040-05-29	U-4273		2025-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	12629377	2040-05-29	U-4539	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	12629377	2040-05-29	U-4540	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	12629377	2040-05-29	U-4541	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218879-001	12636289	2040-05-29		Drug product	2026-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11596634	2040-05-29	U-4271		2025-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11596634	2040-05-29	U-4272		2025-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11596634	2040-05-29	U-4273		2025-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11612566	2040-05-29	U-4271		2025-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11612566	2040-05-29	U-4272		2025-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218879-001	11612566	2040-05-29	U-4273		2025-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11596634	2040-05-29	U-4271		2025-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11596634	2040-05-29	U-4272		2025-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11596634	2040-05-29	U-4273		2025-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11612566	2040-05-29	U-4271		2025-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11612566	2040-05-29	U-4272		2025-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218879-001	11612566	2040-05-29	U-4273		2025-09-26	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11596634	2040-05-29	U-4271		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11596634	2040-05-29	U-4272		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11596634	2040-05-29	U-4273		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11612566	2040-05-29	U-4271		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11612566	2040-05-29	U-4272		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	11612566	2040-05-29	U-4273		2025-09-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	12629377	2040-05-29	U-4539	Drug product	2026-06-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218879-001	12629377	2040-05-29	U-4540	Drug product	2026-06-18	`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
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	022b0913-f683-4af8-a862-f81b315909b2	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218879 application number: NDA218879

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
84669	ORIG	2026-01-06
83377	ORIG	2025-09-18
83360	ORIG	2025-09-17
83359	ORIG	2025-09-16