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

Pharmacology for NDA: 203340

Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 203340

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

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.	24338-230	24338-230-30	12 BLISTER PACK in 1 CARTON (24338-230-30) / 1 SYRINGE, PLASTIC in 1 BLISTER PACK (24338-230-15) / 5 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	3MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 10, 2013	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	6MG/ML
Approval Date:	Apr 8, 2020	TE:		RLD:	Yes
Patent:	10,342,787	Patent Expiration:	Apr 16, 2038	Product Flag?	Y	Substance 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:	10,576,070	Patent Expiration:	Apr 16, 2038	Product Flag?	Y	Substance 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

Expired US Patents for NDA 203340

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	7,070,581	⤷ Subscribe
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	8,517,997	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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