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Generated: October 22, 2018

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Details for New Drug Application (NDA): 040475

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NDA 040475 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Hikma Pharms, Paddock Llc, Sagent Pharms, and West-ward Pharms Int, and is included in four NDAs. It is available from four 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. Seven suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 040475
Tradename:DIHYDROERGOTAMINE MESYLATE
Applicant:Paddock Llc
Ingredient:dihydroergotamine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040475
Ingredient-typeErgotamines
Medical Subject Heading (MeSH) Categories for 040475
Suppliers and Packaging for NDA: 040475
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIHYDROERGOTAMINE MESYLATE dihydroergotamine mesylate INJECTABLE;INJECTION 040475 ANDA Paddock Laboratories, LLC 0574-0850 0574-0850-05 5 AMPULE in 1 CARTON (0574-0850-05) > 1 mL in 1 AMPULE
DIHYDROERGOTAMINE MESYLATE dihydroergotamine mesylate INJECTABLE;INJECTION 040475 ANDA Paddock Laboratories, LLC 0574-0850 0574-0850-10 10 AMPULE in 1 CARTON (0574-0850-10) > 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 28, 2003TE:APRLD:No

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