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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 203340


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NDA 203340 describes NYMALIZE, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the NYMALIZE profile page.

The generic ingredient in NYMALIZE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 203340
Tradename:NYMALIZE
Applicant:Azurity
Ingredient:nimodipine
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 203340
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 Azurity Pharmaceuticals, Inc. 24338-230 24338-230-12 12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC
NYMALIZE nimodipine SOLUTION;ORAL 203340 NDA Azurity Pharmaceuticals, Inc. 24338-260 24338-260-08 237 mL in 1 BOTTLE (24338-260-08)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 10, 2013TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength6MG/ML
Approval Date:Apr 8, 2020TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Apr 16, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS
Patent:⤷  Try a TrialPatent Expiration:Apr 16, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS

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