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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075735
Company: LUPIN

REMS

Products on ANDA 075735

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075735

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2001	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/03/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-13	REMS - PROPOSAL - D-N-A		Label is not available on this site.
04/20/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/20/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/07/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075735

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE;EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	075735	LUPIN
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	075523	SUN PHARM INDS LTD
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	074736	WATSON LABS

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