FDA.reportPublic FDA data

Application 220358

Type
NDA
Sponsor
VANDA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BYSANTIMILSAPERIDONETABLET;ORAL1MGYesYes
002BYSANTIMILSAPERIDONETABLET;ORAL2MGYesNo
003BYSANTIMILSAPERIDONETABLET;ORAL4MGYesNo
004BYSANTIMILSAPERIDONETABLET;ORAL6MGYesNo
005BYSANTIMILSAPERIDONETABLET;ORAL8MGYesNo
006BYSANTIMILSAPERIDONETABLET;ORAL10MGYesNo
007BYSANTIMILSAPERIDONETABLET;ORAL12MGYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220358-001BYSANTIMILSAPERIDONE1MGTABLET / ORALRLD, RS2026-02-20
N220358-002BYSANTIMILSAPERIDONE2MGTABLET / ORALRLD2026-02-20
N220358-003BYSANTIMILSAPERIDONE4MGTABLET / ORALRLD2026-02-20
N220358-004BYSANTIMILSAPERIDONE6MGTABLET / ORALRLD2026-02-20
N220358-005BYSANTIMILSAPERIDONE8MGTABLET / ORALRLD2026-02-20
N220358-006BYSANTIMILSAPERIDONE10MGTABLET / ORALRLD2026-02-20
N220358-007BYSANTIMILSAPERIDONE12MGTABLET / ORALRLD2026-02-20

Orange Book patents#

Current patent rows page 1 of 2 · 140 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220358-001105704532028-03-28U-44362026-03-23
N220358-001105704532028-03-28U-44372026-03-23
N220358-00191571212030-04-05U-44362026-03-23
N220358-00191571212030-04-05U-44372026-03-23
N220358-001105632592030-07-24U-44362026-03-23
N220358-001105632592030-07-24U-44372026-03-23
N220358-001126068692030-09-22U-45062026-05-21
N220358-001126068692030-09-22U-45072026-05-21
N220358-00189996382030-10-28U-44362026-03-23
N220358-00189996382030-10-28U-44372026-03-23
N220358-00190742552030-12-17U-44362026-03-23
N220358-00190742552030-12-17U-44372026-03-23
N220358-00190727422031-01-16U-44362026-03-23
N220358-00190727422031-01-16U-44372026-03-23
N220358-00190742562031-02-10U-44362026-03-23
N220358-00190742562031-02-10U-44372026-03-23
N220358-00190742542031-12-28U-44362026-03-23
N220358-00190742542031-12-28U-44372026-03-23
N220358-001124786192044-05-31U-44342026-03-23
N220358-001124786192044-05-31U-44352026-03-23
N220358-002105704532028-03-28U-44362026-03-23
N220358-002105704532028-03-28U-44372026-03-23
N220358-00291571212030-04-05U-44362026-03-23
N220358-00291571212030-04-05U-44372026-03-23
N220358-002105632592030-07-24U-44362026-03-23
N220358-002105632592030-07-24U-44372026-03-23
N220358-002126068692030-09-22U-45062026-05-21
N220358-002126068692030-09-22U-45072026-05-21
N220358-00289996382030-10-28U-44362026-03-23
N220358-00289996382030-10-28U-44372026-03-23
N220358-00290742552030-12-17U-44362026-03-23
N220358-00290742552030-12-17U-44372026-03-23
N220358-00290727422031-01-16U-44362026-03-23
N220358-00290727422031-01-16U-44372026-03-23
N220358-00290742562031-02-10U-44362026-03-23
N220358-00290742562031-02-10U-44372026-03-23
N220358-00290742542031-12-28U-44362026-03-23
N220358-00290742542031-12-28U-44372026-03-23
N220358-002124786192044-05-31U-44342026-03-23
N220358-002124786192044-05-31U-44352026-03-23
N220358-003105704532028-03-28U-44362026-03-23
N220358-003105704532028-03-28U-44372026-03-23
N220358-00391571212030-04-05U-44362026-03-23
N220358-00391571212030-04-05U-44372026-03-23
N220358-003105632592030-07-24U-44362026-03-23
N220358-003105632592030-07-24U-44372026-03-23
N220358-003126068692030-09-22U-45062026-05-21
N220358-003126068692030-09-22U-45072026-05-21
N220358-00389996382030-10-28U-44362026-03-23
N220358-00389996382030-10-28U-44372026-03-23
N220358-00390742552030-12-17U-44362026-03-23
N220358-00390742552030-12-17U-44372026-03-23
N220358-00390727422031-01-16U-44362026-03-23
N220358-00390727422031-01-16U-44372026-03-23
N220358-00390742562031-02-10U-44362026-03-23
N220358-00390742562031-02-10U-44372026-03-23
N220358-00390742542031-12-28U-44362026-03-23
N220358-00390742542031-12-28U-44372026-03-23
N220358-003124786192044-05-31U-44342026-03-23
N220358-003124786192044-05-31U-44352026-03-23
N220358-004105704532028-03-28U-44362026-03-23
N220358-004105704532028-03-28U-44372026-03-23
N220358-00491571212030-04-05U-44362026-03-23
N220358-00491571212030-04-05U-44372026-03-23
N220358-004105632592030-07-24U-44362026-03-23
N220358-004105632592030-07-24U-44372026-03-23
N220358-004126068692030-09-22U-45062026-05-21
N220358-004126068692030-09-22U-45072026-05-21
N220358-00489996382030-10-28U-44362026-03-23
N220358-00489996382030-10-28U-44372026-03-23
N220358-00490742552030-12-17U-44362026-03-23
N220358-00490742552030-12-17U-44372026-03-23
N220358-00490727422031-01-16U-44362026-03-23
N220358-00490727422031-01-16U-44372026-03-23
N220358-00490742562031-02-10U-44362026-03-23
N220358-00490742562031-02-10U-44372026-03-23
N220358-00490742542031-12-28U-44362026-03-23
N220358-00490742542031-12-28U-44372026-03-23
N220358-004124786192044-05-31U-44342026-03-23
N220358-004124786192044-05-31U-44352026-03-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220358-001NCE2031-02-20
N220358-002NCE2031-02-20
N220358-003NCE2031-02-20
N220358-004NCE2031-02-20
N220358-005NCE2031-02-20
N220358-006NCE2031-02-20
N220358-007NCE2031-02-20

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001BYSANTI1MGTABLET / ORALRLD, RS2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002BYSANTI2MGTABLET / ORALRLD2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-003BYSANTI4MGTABLET / ORALRLD2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-004BYSANTI6MGTABLET / ORALRLD2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-005BYSANTI8MGTABLET / ORALRLD2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-006BYSANTI10MGTABLET / ORALRLD2026-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-007BYSANTI12MGTABLET / ORALRLD2026-02-20a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001105704532028-03-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001105704532028-03-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00191571212030-04-05U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00191571212030-04-05U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001105632592030-07-24U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001105632592030-07-24U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001126068692030-09-22U-45062026-05-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001126068692030-09-22U-45072026-05-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00189996382030-10-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00189996382030-10-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742552030-12-17U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742552030-12-17U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190727422031-01-16U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190727422031-01-16U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742562031-02-10U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742562031-02-10U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742542031-12-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00190742542031-12-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001124786192044-05-31U-44342026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001124786192044-05-31U-44352026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002105704532028-03-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002105704532028-03-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00291571212030-04-05U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00291571212030-04-05U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002105632592030-07-24U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002105632592030-07-24U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002126068692030-09-22U-45062026-05-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002126068692030-09-22U-45072026-05-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00289996382030-10-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00289996382030-10-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742552030-12-17U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742552030-12-17U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290727422031-01-16U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290727422031-01-16U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742562031-02-10U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742562031-02-10U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742542031-12-28U-44372026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-00290742542031-12-28U-44362026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002124786192044-05-31U-44352026-03-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002124786192044-05-31U-44342026-03-23a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-001NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-002NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-003NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-004NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-005NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-006NCE2031-02-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220358-007NCE2031-02-20a50c72e98297…

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
BYSANTIMILSAPERIDONEVanda Pharmaceuticals Inc.254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f82026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220358
application number: NDA220358

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85314ORIG 2026-03-10
85313ORIG 2026-03-10
85157ORIG 2026-02-25
85114ORIG 2026-02-24