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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 213436

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NDA 213436 describes TRUDHESA, which is a drug marketed by Impel Pharms and is included in one NDA. There are six patents protecting this drug. Additional details are available on the TRUDHESA profile page.

The generic ingredient in TRUDHESA is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 213436
Applicant:Impel Pharms
Ingredient:dihydroergotamine mesylate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 213436

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.725MG/SPRAY
Approval Date:Sep 2, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 2, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Patent:See Plans and PricingPatent Expiration:Dec 25, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Jan 23, 2033Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

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