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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 216937

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NDA 216937 describes NIMODIPINE, which is a drug marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Annora Pharma, and is included in six NDAs. It is available from three suppliers. Additional details are available on the NIMODIPINE profile page.

The generic ingredient in NIMODIPINE 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 216937

Tradename:	NIMODIPINE
Applicant:	Annora Pharma
Ingredient:	nimodipine
Patents:	0

Pharmacology for NDA: 216937

Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 216937

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Suppliers and Packaging for NDA: 216937

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIMODIPINE	nimodipine	SOLUTION;ORAL	216937	ANDA	Camber Pharmaceuticals, Inc.	31722-039	31722-039-47	473 mL in 1 BOTTLE (31722-039-47)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	3MG/ML
Approval Date:	Jul 9, 2024	TE:		RLD:	No

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