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Generated: November 12, 2018

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Details for New Drug Application (NDA): 005929

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NDA 005929 describes D.H.E. 45, which is a drug marketed by Valeant and is included in one NDA. It is available from one supplier. Additional details are available on the D.H.E. 45 profile page.

The generic ingredient in D.H.E. 45 is dihydroergotamine mesylate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 005929
Tradename:D.H.E. 45
Applicant:Valeant
Ingredient:dihydroergotamine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 005929
Ingredient-typeErgotamines
Medical Subject Heading (MeSH) Categories for 005929
Suppliers and Packaging for NDA: 005929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
D.H.E. 45 dihydroergotamine mesylate INJECTABLE;INJECTION 005929 NDA Valeant Pharmaceuticals North America 66490-041 66490-041-01 10 AMPULE in 1 CARTON (66490-041-01) > 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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