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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211785
Company: MYLAN TECHNOLOGIES

REMS

Products on ANDA 211785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	AB	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2020	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
03/20/2024	SUPPL-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/16/2022	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/03/2022	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 211785

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

FILM;BUCCAL, SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205954	ALVOGEN
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205299	DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	211785	MYLAN TECHNOLOGIES
SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	Yes	AB	022410	INDIVIOR

FILM;BUCCAL, SUBLINGUAL; EQ 4MG BASE;EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205954	ALVOGEN
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205806	DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	211785	MYLAN TECHNOLOGIES
SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	Yes	AB	022410	INDIVIOR

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