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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205806
Company: DR REDDYS LABS SA

REMS

Products on ANDA 205806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	AB	No	No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205806Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2024	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/16/2022	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/06/2022	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/31/2018	SUPPL-1	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 205806

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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

FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG 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 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205954	ALVOGEN
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	212756	AVEVA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	205806	DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	No	AB	207607	MYLAN TECHNOLOGIES
SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription	Yes	AB	022410	INDIVIOR

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