FDA.reportPublic FDA data

Application 215400

Type
NDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREKIYA (AUTOINJECTOR)DIHYDROERGOTAMINE MESYLATESOLUTION;SUBCUTANEOUS1MG/MLYesYes

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
N215400-001BREKIYA (AUTOINJECTOR)DIHYDROERGOTAMINE MESYLATE1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215400-001105320492039-02-26Drug product2025-05-28
N215400-001113049422039-02-26Drug product2025-05-28
N215400-001118195012039-02-26U-41882025-05-28
N215400-001118195012039-02-26U-8482025-05-28
N215400-001125333512039-02-26Drug product2026-02-26
N215400-001115410432039-03-20Drug product2026-05-26
N215400-001123297492039-05-27U-2718Drug product2026-05-26
N215400-001123297492039-05-27U-4508Drug product2026-05-26
N215400-001110837122039-06-30U-2718Drug product2026-05-26
N215400-001110837122039-06-30U-4508Drug product2026-05-26
N215400-001124149412039-08-24Drug product2026-05-26

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 UTC2026-02N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215400-001105320492039-02-26Drug product2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001113049422039-02-26Drug product2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001118195012039-02-26U-8482025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001118195012039-02-26U-41882025-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001105320492039-02-26Drug product2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001113049422039-02-26Drug product2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001118195012039-02-26U-8482025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001118195012039-02-26U-41882025-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215400-001105320492039-02-26Drug product2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001113049422039-02-26Drug product2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001118195012039-02-26U-8482025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001118195012039-02-26U-41882025-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001105320492039-02-26Drug product2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001113049422039-02-26Drug product2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001118195012039-02-26U-8482025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001118195012039-02-26U-41882025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001125333512039-02-26Drug product2026-02-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001115410432039-03-20Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001123297492039-05-27U-2718Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001123297492039-05-27U-4508Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001110837122039-06-30U-2718Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001110837122039-06-30U-4508Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001124149412039-08-24Drug product2026-05-26a50c72e98297…

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
BREKIYADIHYDROERGOTAMINE MESYLATEAmneal Pharmaceuticals LLCcdbf5619-767f-4165-aec2-17bdd92d9ca22025-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215400
application number: NDA215400

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85753ORIG 2026-04-27
82303ORIG 2025-05-23
82292ORIG 2025-05-14
82291ORIG 2025-05-14