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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
UBS
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Moodys
Cerilliant
Merck
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203340

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NDA 203340 describes NYMALIZE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NYMALIZE profile page.

The generic ingredient in NYMALIZE is nimodipine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 203340
Tradename:NYMALIZE
Applicant:Arbor Pharms Llc
Ingredient:nimodipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203340
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 203340
Suppliers and Packaging for NDA: 203340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYMALIZE nimodipine SOLUTION;ORAL 203340 NDA Arbor Pharmaceuticals 24338-200 N 24338-200-12
NYMALIZE nimodipine SOLUTION;ORAL 203340 NDA Arbor Pharmaceuticals 24338-200 N 24338-200-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength60MG/20ML
Approval Date:May 10, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 10, 2020
Regulatory Exclusivity Use:IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS REGARDLESS OF THEIR POST-ICTUS NEUROLOGICAL CONDITION

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Colorcon
AstraZeneca
Covington
Daiichi Sankyo
Medtronic
Accenture
Chinese Patent Office
Healthtrust

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