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Last Updated: December 15, 2024

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 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL
Sun Pharm Industries	buprenorphine hydrochloride; naloxone hydrochloride	214737	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET;SUBLINGUAL
Sun Pharm Industries	buprenorphine hydrochloride; naloxone hydrochloride	214737	EQ 11.4MG BASE;EQ 2.9MG 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 5.7MG BASE;EQ 1.4MG BASE	TABLET;SUBLINGUAL
Actavis Labs Ut Inc	buprenorphine hydrochloride; naloxone hydrochloride	204383	EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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