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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075523
Company: SUN PHARM INDS LTD

Safety Labeling Change Order Letter

REMS

Products on ANDA 75523

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

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