FDA.reportPublic FDA data

Application 005929

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001D.H.E. 45DIHYDROERGOTAMINE MESYLATEINJECTABLE;INJECTION1MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N005929-001D.H.E. 45DIHYDROERGOTAMINE MESYLATE1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N005929-001D.H.E. 451MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N005929-001D.H.E. 451MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N005929-001D.H.E. 451MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N005929-001D.H.E. 451MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N005929-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N005929-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N005929-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N005929-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N005929-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N005929-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N005929-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N005929-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N005929-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N005929-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N005929-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N005929-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N005929-001AP1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N005929-001AP1cb3db0bc1861…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrudhesaDIHYDROERGOTAMINE MESYLATEImpel Pharmaceuticals LLCb81397b0-910d-4eb4-8fee-a9a3c9d94d632026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
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
generic name: DIHYDROERGOTAMINE MESYLATE
DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATESomerset Therapeutics, LLCc8ffdc19-a90d-453c-b094-2347e116b4052026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATEAdvagen Pharma Ltd65f8c60d-9213-48ac-8233-acc5d44548f42026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEHikma Pharmaceuticals USA Inc.9ffe6d5a-7348-0498-e053-2a95a90a97a82025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
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
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEOceanside Pharmaceuticals977de209-c53a-4cb4-9f3f-1e850600a9dc2025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEProvepharm Inc.40b9ba9e-436e-444e-b078-01b12bb57ea72025-02-25Boxed 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
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEGland Pharma Limited07a9112c-8c04-4849-8cb3-9463f58731d22023-08-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATEBaxter Healthcare Corporationf87dcd07-90ef-4e37-853e-7a5911a038b12023-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE
Dihydroergotamine MesylateDIHYDROERGOTAMINE MESYLATEHikma Pharmaceuticals USA Inc.683ca944-efa7-4ca3-9cbe-cf0e7ffb1d642023-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIHYDROERGOTAMINE MESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66490-041D.H.E. 45Dihydroergotamine MesylateBausch Health US, LLCNDACurrent
66490-041D.H.E. 45Dihydroergotamine MesylateBausch Health US, LLCNDACurrent
66490-041D.H.E. 45Dihydroergotamine MesylateValeant Pharmaceuticals North AmericaNDACurrent
66490-041D.H.E. 45Dihydroergotamine MesylateBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71044SUPPL2022-05-11
71029SUPPL2022-05-10
49009SUPPL2017-07-18
68SUPPL2003-07-31
18SUPPL2003-07-31
32934SUPPL2003-05-08
10678SUPPL2003-05-08