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Serving 500+ biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
Johnson and Johnson
QuintilesIMS
Deloitte
Chubb
Federal Trade Commission
Cerilliant
Queensland Health
Novartis

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018885

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NDA 018885 describes EMBOLEX, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the EMBOLEX profile page.

The generic ingredient in EMBOLEX is dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride. There are five drug master file entries for this compound. Additional details are available on the dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride profile page.

Summary for NDA: 018885

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.5MG/0.5ML;2,500 UNITS/0.5ML;5.33MG/0.5ML
Approval Date:Nov 30, 1984TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.5MG/0.7ML;5,000 UNITS/0.7ML;7.46MG/0.7ML
Approval Date:Nov 30, 1984TE:RLD:No

Expired Orange Book Patents for NDA: 018885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EMBOLEX
dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride
INJECTABLE;INJECTION018885-001Nov 30, 1984► Subscribe► Subscribe
Novartis
EMBOLEX
dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride
INJECTABLE;INJECTION018885-002Nov 30, 1984► Subscribe► Subscribe
Novartis
EMBOLEX
dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride
INJECTABLE;INJECTION018885-001Nov 30, 1984► Subscribe► Subscribe
Novartis
EMBOLEX
dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride
INJECTABLE;INJECTION018885-002Nov 30, 1984► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
AstraZeneca
Chubb
Citi
McKinsey
Fish and Richardson
McKesson
Teva
US Department of Justice

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