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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207868


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NDA 207868 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 207868
Tradename:NICOTINE POLACRILEX
Applicant:Pld Acquisitions
Ingredient:nicotine polacrilex
Patents:0
Pharmacology for NDA: 207868
Suppliers and Packaging for NDA: 207868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 207868 ANDA Walgreens 0363-0262 0363-0262-08 4 BOTTLE, PLASTIC in 1 BOX (0363-0262-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC
NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 207868 ANDA Walgreens 0363-0262 0363-0262-20 1 BOTTLE, PLASTIC in 1 BOX (0363-0262-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:Feb 7, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:Feb 7, 2019TE:RLD:No

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