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NICOTINE POLACRILEX

ANDA

NICOTINE POLACRILEX | A209206 | P AND L DEVELOPMENT LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs4 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

NICOBRAND LTDNICOTINE POLACRILEX RESIN

DMF 107391994

LABORATORIOS HAYMANN SANICOTINE POLACRILEX USP , 20%

DMF 169102003

FERTIN PHARMA ASNICOTINE POLACRILEX USP

DMF 201232007

SIEGFRIED LTDNICOTINE POLACRILEX 20%

DMF 221552008

BGP HEALTHCARE PRIVATE LTDNICOTINE POLACRILEX 20% USP

DMF 238382010

KENVUE BRANDS LLCNICOTINE POLACRILEX LOZENGE

DMF 322002018

FERTIN PHARMA ASNICOTINE POLACRILEX USP

DMF 356472021

NICOBRAND LTDNICOTINE POLACRILEX 20%

DMF 384412024

INDIA GLYCOLS LTDNICOTINE POLACRILEX USP

DMF 398692024

WYCKOFF CHEMICAL CO INCInactiveNICOTINE POLACRILEX

DMF 76541988

FINE CHEMICALS CORPInactiveNICOTINE POLACRILEX

DMF 105271993

SALSBURY CHEMICALS INCInactiveNICOTINE POLACRILEX RESIN

DMF 141931999

SMS PHARMACEUTICALS LTDInactiveNICOTINE POLACRILEX USP

DMF 219782008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 2MG BASE

0 patents0 exclusivities▴

TROCHE/LOZENGE;ORAL | Approved: Jun 26, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE

0 patents0 exclusivities▾

TROCHE/LOZENGE;ORAL | Approved: Jun 26, 2018