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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 216747

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NDA 216747 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 seven 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. Eleven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.

Summary for 216747

Tradename:	DIHYDROERGOTAMINE MESYLATE
Applicant:	Baxter Hlthcare Corp
Ingredient:	dihydroergotamine mesylate
Patents:	0

Pharmacology for NDA: 216747

Medical Subject Heading (MeSH) Categories for 216747

Analgesics, Non-Narcotic
Dopamine Agonists
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 216747

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	216747	ANDA	Baxter Healthcare Corporation	36000-300	36000-300-10	10 AMPULE in 1 CARTON (36000-300-10) / 1 mL in 1 AMPULE (36000-300-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Jan 7, 2025	TE:		RLD:	No

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