Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219302
Company: SOMERSET THERAPS LLC

Products on ANDA 219302

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219302

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 219302

BUPRENORPHINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 0.3MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076931	HIKMA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074137	HOSPIRA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206586	PH HEALTH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	219302	SOMERSET THERAPS LLC