Details for New Drug Application (NDA): 075523

NDA 075523 describes NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, which is a drug marketed by Lupin, Sun Pharm Inds Ltd, and Watson Labs, and is included in three NDAs. It is available from three suppliers. Additional details are available on the NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for 075523

Tradename:	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	naloxone hydrochloride; pentazocine hydrochloride
Patents:	0

Pharmacology for NDA: 075523

Mechanism of Action

Competitive Opioid Antagonists Opioid Antagonists Partial Opioid Agonists

Suppliers and Packaging for NDA: 075523

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075523	ANDA	Sun Pharmaceutical Industries, Inc.	63304-506	63304-506-01	100 TABLET in 1 BOTTLE (63304-506-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.5MG BASE;EQ 50MG BASE
Approval Date:	Mar 17, 2000	TE:	AB	RLD:	No

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