Last Updated: June 7, 2026

Generic Companies with Tentative Approvals for: amlodipine besylate

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amlodipine besylate Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Zydus Pharms Usa Inc	amlodipine besylate; benazepril hydrochloride	078652	5MG; 10MG	CAPSULE; ORAL
Zydus Pharms Usa Inc	amlodipine besylate; benazepril hydrochloride	078652	2.5MG; 10MG	CAPSULE; ORAL
Matrix Labs Ltd	amlodipine besylate; olmesartan medoxomil	090398	5MG/40MG	TABLET; ORAL
Gedeon Richter Usa	amlodipine besylate	077333	EQ 2.5MG BASE	TABLET;ORAL
Matrix Labs Ltd	amlodipine besylate; olmesartan medoxomil	090398	10MG/40MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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