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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 213409

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NDA 213409 describes NIMODIPINE, which is a drug marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, Alkem Labs Ltd, and Annora Pharma, and is included in seven 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 213409

Tradename:	NIMODIPINE
Applicant:	Alkem Labs Ltd
Ingredient:	nimodipine
Patents:	0

Medical Subject Heading (MeSH) Categories for 213409

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	6MG/ML
Approval Date:	Jan 22, 2025	TE:	AB	RLD:	No

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