Last Updated: July 18, 2026

Generic Companies with Tentative Approvals for: buprenorphine hydrochloride; naloxone hydrochloride

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buprenorphine hydrochloride; naloxone hydrochloride 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
Sun Pharm Industries	buprenorphine hydrochloride; naloxone hydrochloride	214737	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET;SUBLINGUAL
Sun Pharm Industries	buprenorphine hydrochloride; naloxone hydrochloride	214737	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET;SUBLINGUAL
Sun Pharm Industries	buprenorphine hydrochloride; naloxone hydrochloride	214737	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET;SUBLINGUAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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