FDA.reportPublic FDA data

Application 218637

Type
NDA
Sponsor
KAMAT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RALDESYTRAZODONE HYDROCHLORIDESOLUTION;ORAL10MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218637-001RALDESYTRAZODONE HYDROCHLORIDE10MG/MLSOLUTION / ORALRLD, RS2024-11-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218637-00181338932029-03-13Drug substance, Drug product2024-12-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-262680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218637-001RALDESY10MG/MLSOLUTION / ORALRLD, RS2024-11-26a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N218637-00181338932029-03-13Drug substance, Drug product2024-12-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218637-00181338932029-03-13Drug substance, Drug product2024-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218637-00181338932029-03-13Drug substance, Drug product2024-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218637-00181338932029-03-13Drug substance, Drug product2024-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218637-00181338932029-03-13Drug substance, Drug product2024-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218637-00181338932029-03-13Drug substance, Drug product2024-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218637-00181338932029-03-13Drug substance, Drug product2024-12-0403ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218637-00181338932029-03-13Drug substance, Drug product2024-12-04a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RALDESY TMTRAZODONE HYDROCHLORIDE ORALValidus Pharmaceuticals LLC34708cc1-b0b2-4fd0-b9f3-7f008b457fc92026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218637
application number: NDA218637

Documents#

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