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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 077007


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NDA 077007 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 fifty NDAs. It is available from fifty-eight 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. Fifty-nine suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 077007
Tradename:NICOTINE POLACRILEX
Applicant:Perrigo R And D
Ingredient:nicotine polacrilex
Patents:0
Pharmacology for NDA: 077007
Suppliers and Packaging for NDA: 077007
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007 ANDA L. Perrigo Company 0113-0344 0113-0344-05 3 CONTAINER in 1 CARTON (0113-0344-05) / 24 LOZENGE in 1 CONTAINER
NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007 ANDA L. Perrigo Company 0113-0344 0113-0344-14 8 CONTAINER in 1 CARTON (0113-0344-14) / 27 LOZENGE in 1 CONTAINER (0113-0344-09)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:Jan 31, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:Jan 31, 2006TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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