Application 218637

Type: NDA
Sponsor: KAMAT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RALDESY	TRAZODONE HYDROCHLORIDE	SOLUTION;ORAL	10MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N218637-001	RALDESY	TRAZODONE HYDROCHLORIDE	10MG/ML	SOLUTION / ORAL		RLD, RS	2024-11-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218637-001	8133893	2029-03-13		Drug substance, Drug product	2024-12-04

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N218637-001	RALDESY	10MG/ML	SOLUTION / ORAL		RLD, RS	2024-11-26	`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
2026-08-01 22:54:32	2026-06	N218637-001	8133893	2029-03-13		Drug substance, Drug product	2024-12-04	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
RALDESY TM	TRAZODONE HYDROCHLORIDE ORAL	Validus Pharmaceuticals LLC	34708cc1-b0b2-4fd0-b9f3-7f008b457fc9	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218637 application number: NDA218637

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84216	SUPPL	2025-11-19
84215	SUPPL	2025-11-19
84214	SUPPL	2025-11-19
83778	SUPPL	2025-10-15
83777	SUPPL	2025-10-15
83024	ORIG	2025-08-01
82659	SUPPL	2025-06-25
80463	ORIG	2024-12-02
80438	ORIG	2024-11-29