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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215035

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NDA 215035 describes AMLODIPINE BENZOATE, which is a drug marketed by Amneal and is included in one NDA. Additional details are available on the AMLODIPINE BENZOATE profile page.

The generic ingredient in AMLODIPINE BENZOATE is amlodipine benzoate. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine benzoate profile page.

Summary for 215035

Tradename:	AMLODIPINE BENZOATE
Applicant:	Amneal
Ingredient:	amlodipine benzoate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 1MG BASE/ML
Approval Date:	Jun 13, 2023	TE:		RLD:	No

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