FDA.reportPublic FDA data

Application 207264

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATEINJECTABLE;INJECTION1MG/MLNoNo

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
A207264-001DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2018-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207264-001AP

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
2026-08-01 22:54:322026-06A207264-001DIHYDROERGOTAMINE MESYLATE1MG/MLINJECTABLE / INJECTIONAP2018-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207264-001AP1a50c72e98297…

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 · 14 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 reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEMilla Pharmaceuticals Inc.b464a64d-b150-4f6b-b3df-e486a41294d72026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATESomerset Therapeutics, LLCc8ffdc19-a90d-453c-b094-2347e116b4052026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DIHYDROERGOTAMINE MESYLATE
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATEAdvagen Pharma Ltd65f8c60d-9213-48ac-8233-acc5d44548f42026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEHikma Pharmaceuticals USA Inc.9ffe6d5a-7348-0498-e053-2a95a90a97a82025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
BREKIYADIHYDROERGOTAMINE MESYLATEAmneal Pharmaceuticals LLCcdbf5619-767f-4165-aec2-17bdd92d9ca22025-10-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATETrifluent Pharma, LLC4cb78f66-6ccf-4ac7-8599-e199f6995f052025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEOceanside Pharmaceuticals977de209-c53a-4cb4-9f3f-1e850600a9dc2025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEProvepharm Inc.40b9ba9e-436e-444e-b078-01b12bb57ea72025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
TrudhesaDIHYDROERGOTAMINE MESYLATEImpel Pharmaceuticals LLCb81397b0-910d-4eb4-8fee-a9a3c9d94d632025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEHikma Pharmaceuticals USA Inc.3fbec3be-9f30-448e-89b9-367a55ed4c972024-03-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEGland Pharma Limited07a9112c-8c04-4849-8cb3-9463f58731d22023-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATEBaxter Healthcare Corporationf87dcd07-90ef-4e37-853e-7a5911a038b12023-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dihydroergotamine mesylate
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEHikma Pharmaceuticals USA Inc.683ca944-efa7-4ca3-9cbe-cf0e7ffb1d642023-03-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dihydroergotamine Mesylate
generic name: DIHYDROERGOTAMINE MESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-609dihydroergotamine mesylatedihydroergotamine mesylateSagent PharmaceuticalsANDACurrent
25021-609dihydroergotamine mesylatedihydroergotamine mesylateSagent PharmaceuticalsANDACurrent