Last Updated: May 4, 2026

Details for New Drug Application (NDA): 215228

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NDA 215228 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Cipla, Gland, Hikma, Hikma Pharms, Milla Pharms, Padagis Us, Sagent Pharms Inc, Amneal, Rubicon Research, and Somerset Theraps Llc, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the DIHYDROERGOTAMINE MESYLATE profile page.

The generic ingredient in DIHYDROERGOTAMINE MESYLATE is dihydroergotamine mesylate. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.

Summary for 215228

Tradename:	DIHYDROERGOTAMINE MESYLATE
Applicant:	Somerset Theraps Llc
Ingredient:	dihydroergotamine mesylate
Patents:	0

Pharmacology for NDA: 215228

Medical Subject Heading (MeSH) Categories for 215228

Analgesics, Non-Narcotic
Dopamine Agonists
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 215228

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	215228	ANDA	Somerset Therapeutics, LLC	70069-880	70069-880-08	8 CARTON in 1 KIT (70069-880-08) / 1 VIAL in 1 CARTON (70069-880-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.5MG/SPRAY
Approval Date:	Feb 26, 2025	TE:	AB	RLD:	No

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