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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040475

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NDA 040475 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by West-ward Pharms Int and Paddock Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the DIHYDROERGOTAMINE MESYLATE profile page.

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

Summary for NDA: 040475

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040475

Ingredient-typeErgotamines

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

Summary for product number 001

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


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