FDA.reportPublic FDA data

Application 076569

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 2MG BASENoNo
002NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreen CompanyANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby LaboratoriesANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
17856-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexATLANTIC BIOLOGICALS CORP.ANDACurrent
46122-724Nicotinenicotine polacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31141ORIG2004-07-30