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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204442

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NDA 204442 describes PROBUPHINE, which is a drug marketed by Reacx Pharms and is included in one NDA. Additional details are available on the PROBUPHINE profile page.

The generic ingredient in PROBUPHINE is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for 204442

Tradename:	PROBUPHINE
Applicant:	Reacx Pharms
Ingredient:	buprenorphine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	IMPLANT;IMPLANTATION			Strength	EQ 80MG BASE/IMPLANT
Approval Date:	May 26, 2016	TE:		RLD:	Yes

Expired US Patents for NDA 204442

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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