Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206586
Company: ENDO OPERATIONS

Products on ANDA 206586

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206586Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/23/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206586

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	206586	ENDO OPERATIONS
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