FDA.reportPublic FDA data

Application 078325

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0206good sense nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0206good sense nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0761basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0761basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0761basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0904-5736NicoreliefNicotine PolacrilexMajor PharmaceuticalsANDACurrent
11673-206up and up nicotine polacrilexNicotine PolacrilexTarget CorporationANDACurrent
11673-206up and up nicotine polacrilexNicotine PolacrilexTarget CorporationANDACurrent
17856-5736NicoreliefNicotine PolacrilexAtlantic Biologicals CorpsANDACurrent
24385-594Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
24385-594Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
30142-206nicotineNicotine PolacrilexKroger CompanyANDACurrent
36800-206Topcare NicotineNicotine PolacrilexTopco Associates LLCANDACurrent
36800-206Topcare NicotineNicotine PolacrilexTopco Associates LLCANDACurrent
37808-206In Control NicotineNicotine PolacrilexH E BANDACurrent
37808-206In Control NicotineNicotine PolacrilexH E BANDACurrent
37808-911NicotinenicotineH E BANDACurrent
37808-911NicotinenicotineH E BANDACurrent
41250-206nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-206nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-206nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
45802-206Nicotine PolacrilexNicotine PolacrilexPerrigo New York IncANDACurrent
45802-206Nicotine PolacrilexNicotine PolacrilexPerrigo New York IncANDACurrent
46122-171Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
46122-171Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
46122-171Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
49035-206equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-206equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-206equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49348-691Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-691Sunmark NicotineNicotine PolacrilexMcKessonANDACurrent
49348-691Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-691Sunmark NicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
50090-1145NicoreliefNicotine PolacrilexA-S Medication SolutionsANDACurrent
62011-0047health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
62011-0047health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
62011-0047health mart nicotineNicotine PolacrilexMcKessonANDACurrent
62011-0047health mart nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
64725-0691Sunmark NicotineNicotine PolacrilexTYA PharmaceuticalsANDACurrent
72288-206basic care nicotineNicotine PolacrilexAmazon.com Services LLCANDACurrent
72288-206basic care nicotineNicotine PolacrilexAmazon.com Services LLCANDACurrent