FDA.reportPublic FDA data

Application 078326

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0422Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0422Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0749basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0749basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0749basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0904-5737NicoreliefNicotine PolacrilexMajor PharmaceuticalsANDACurrent
0904-5737NicoreliefNicotine PolacrilexMajor PharmaceuticalsANDACurrent
11673-422up and up nicotineNicotine PolacrilexTarget CorporationANDACurrent
11673-422up and up nicotineNicotine PolacrilexTarget CorporationANDACurrent
17856-5734NicoreliefNicotine PolacrilexATLANTIC BIOLOGICALS CORP.ANDACurrent
24385-598Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
24385-598Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
37808-422In Control NicotineNicotine PolacrilexH E BANDACurrent
37808-422In Control NicotineNicotine PolacrilexH E BANDACurrent
37808-753NicotinenicotineH E BANDACurrent
37808-753NicotinenicotineH E BANDACurrent
41250-422nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-422nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-422nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
45802-001Nicotine PolacrilexNicotine PolacrilexPerrigo New York IncANDACurrent
45802-001Nicotine PolacrilexNicotine PolacrilexPerrigo New York IncANDACurrent
46122-172Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
46122-172Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
46122-172Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
49035-422equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-422equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-422equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49348-692Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-692Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-692Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-692Sunmark NicotineNicotine PolacrilexMcKessonANDACurrent
50090-4265Sunmark NicotineNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-4265Sunmark NicotineNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-4985Nicotine PolacrilexNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-4985Nicotine PolacrilexNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-4985Nicotine PolacrilexNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-4985Nicotine PolacrilexNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-6240GOOD SENSENicotine PolacrilexA-S Medication SolutionsANDACurrent
55316-422Healthy Accents NicotineNicotine PolacrilexDZA Brands LLCANDACurrent
59779-087nicotine polacrilexNicotine PolacrilexCVS PharmacyANDACurrent
62011-0170health mart nicotineNicotine PolacrilexMcKessonANDACurrent
62011-0170health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
62011-0170health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
62011-0170health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
72288-422basic care nicotineNicotine PolacrilexAmazon.com Services LLCANDACurrent