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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218473
Company: SPECGX LLC

Products on ANDA 218473

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218473

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090819	ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	219401	ASCENT PHARMS INC
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090622	ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	078633	HIKMA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	207276	RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090279	RUBICON RESEARCH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	218473	SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	201760	SUN PHARM

TABLET;SUBLINGUAL; EQ 8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090819	ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	219401	ASCENT PHARMS INC
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090622	ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	078633	HIKMA
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	207276	RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	090279	RUBICON RESEARCH
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	218473	SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	201760	SUN PHARM

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