Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214737
Company: SUN PHARM INDUSTRIES

Products on ANDA 214737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.