FDA.reportPublic FDA data

Application 217901

Type
NDA
Sponsor
SATSUMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATZUMIDIHYDROERGOTAMINE MESYLATEPOWDER;NASALEQ 5.2MG BASEYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217901-001ATZUMIDIHYDROERGOTAMINE MESYLATEEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217901-001125942732033-09-24Drug product2026-05-04
N217901-001107922532037-08-04Drug product2025-05-23
N217901-001118723142037-08-04Drug product2025-05-23
N217901-001107585322039-12-11Drug product2025-05-23
N217901-001122631622039-12-11Drug product2025-05-23
N217901-001117449672041-10-12Drug product2025-05-23
N217901-001121027542041-10-12Drug product2025-05-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217901-001NP2028-04-30

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
2026-02-19 14:30 UTC2026-02N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217901-001107922532037-08-04Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001118723142037-08-04Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001107585322039-12-11Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001122631622039-12-11Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001117449672041-10-12Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001121027542041-10-12Drug product2025-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001107922532037-08-04Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001118723142037-08-04Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001107585322039-12-11Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001122631622039-12-11Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001117449672041-10-12Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001121027542041-10-12Drug product2025-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001107922532037-08-04Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001118723142037-08-04Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001107585322039-12-11Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001122631622039-12-11Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001117449672041-10-12Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001121027542041-10-12Drug product2025-05-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001125942732033-09-24Drug product2026-05-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001107922532037-08-04Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001118723142037-08-04Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001107585322039-12-11Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001122631622039-12-11Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001117449672041-10-12Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001121027542041-10-12Drug product2025-05-23a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217901-001NP2028-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001NP2028-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001NP2028-04-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001NP2028-04-30a50c72e98297…

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
ATZUMIDIHYDROERGOTAMINE MESYLATESatsuma Pharmaceuticals, Inc.0982a44a-dc0c-75c0-e063-6394a90a6d6c2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217901
application number: NDA217901

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82149ORIG 2025-05-05
82285ORIG 2025-04-30
82284ORIG 2025-04-30