Details for New Drug Application (NDA): 213233

NDA 213233 describes NICOTINE POLACRILEX, which is a drug marketed by Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac, and is included in forty-nine NDAs. It is available from sixty suppliers. Additional details are available on the NICOTINE POLACRILEX profile page.

The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 213233

Tradename:	NICOTINE POLACRILEX
Applicant:	Dr Reddys Labs Sa
Ingredient:	nicotine polacrilex
Patents:	0

Pharmacology for NDA: 213233

Suppliers and Packaging for NDA: 213233

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213233	ANDA	Dr. Reddy's Laboratories Inc.	43598-488	43598-488-10	4 BOTTLE in 1 CARTON (43598-488-10) / 27 LOZENGE in 1 BOTTLE
NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213233	ANDA	Dr. Reddy's Laboratories Inc.	43598-488	43598-488-12	5 BOTTLE in 1 CARTON (43598-488-12) / 24 LOZENGE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Aug 4, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Aug 4, 2020	TE:		RLD:	No

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