FDA.reportPublic FDA data

Application 076775

Type
ANDA
Sponsor
L PERRIGO CO

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
0113-0029Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0029Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0029Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-0029Good Sense NicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-7029basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-7029basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0113-7029basic care nicotineNicotine PolacrilexL. Perrigo CompanyANDACurrent
0904-5734nicoreliefNicotine PolacrilexMajor PharmaceuticalsANDACurrent
11673-029Up and Up NicotineNicotine PolacrilexTarget CorporationANDACurrent
11673-029Up and Up NicotineNicotine PolacrilexTarget CorporationANDACurrent
11673-029Up and Up NicotineNicotine PolacrilexTarget CorporationANDACurrent
11822-0029NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-0029NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-0029NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
21130-229signature care nicotineNicotine PolacrilexSafewayANDACurrent
21130-229signature care nicotineNicotine PolacrilexSafewayANDACurrent
30142-029nicotineNicotine PolacrilexKroger CompanyANDACurrent
30142-029nicotineNicotine PolacrilexKroger CompanyANDACurrent
30142-029nicotineNicotine PolacrilexKroger CompanyANDACurrent
36800-029TopCare NicotineNicotine PolacrilexTopco Associates LLCANDACurrent
36800-029TopCare NicotineNicotine PolacrilexTopco Associates LLCANDACurrent
37808-029In control nicotineNicotine PolacrilexH E BANDACurrent
37808-029In control nicotineNicotine PolacrilexH E BANDACurrent
37808-029In control nicotineNicotine PolacrilexH E BANDACurrent
37808-781nicotinenicotine polacrilexH E BANDACurrent
37808-781nicotinenicotine polacrilexH E BANDACurrent
41163-029equaline nicotineNicotine PolacrilexSupervalu IncANDACurrent
41250-029nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-029nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41250-029nicotineNicotine PolacrilexMeijer Distribution IncANDACurrent
41520-792CareOne nicotineNicotine PolacrilexAmerican Sales CompanyANDACurrent
41520-792CareOne nicotineNicotine PolacrilexAmerican Sales CompanyANDACurrent
46122-173Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
46122-173Good Neighbor Pharmacy NicotineNicotine PolacrilexAmerisource BergenANDACurrent
49035-029Equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-029Equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-029Equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-029Equate nicotineNicotine PolacrilexWal-Mart Stores IncANDACurrent
49348-573sunmark nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-573sunmark nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-573sunmark nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-573sunmark nicotineNicotine PolacrilexStrategic Sourcing Services LLCANDACurrent
49348-573sunmark nicotineNicotine PolacrilexMcKessonANDACurrent
55316-029healthy accents nicotineNicotine PolacrilexDZA Brands LLCANDACurrent
59779-029nicotineNicotine PolacrilexCVS PharmacyANDACurrent
63981-029kirkland signature quit 2Nicotine PolacrilexCostco Wholesale CompanyANDACurrent
63981-029kirkland signature quit 2Nicotine PolacrilexCostco Wholesale CompanyANDACurrent
63981-029kirkland signature quit 2Nicotine PolacrilexCostco Wholesale CompanyANDACurrent
68196-029members mark nicotineNicotine PolacrilexSam's West IncANDACurrent
68196-029members mark nicotineNicotine PolacrilexSam's West IncANDACurrent
68196-029members mark nicotineNicotine PolacrilexSam's West IncANDACurrent
68196-029members mark nicotineNicotine PolacrilexSam's West IncANDACurrent
68391-029berkley and jensen nicotineNicotine PolacrilexBJWCANDACurrent
68391-029berkley and jensen nicotineNicotine PolacrilexBJWCANDACurrent
70000-0116leader nicotineNicotine PolacrilexCardinal HealthANDACurrent
70925-029Humana Pharmacy NicotineNicotine PolacrilexHumana Pharmacy, Inc.ANDACurrent
72288-029basic care nicotineNicotine PolacrilexAmazon.com Services LLCANDACurrent
72288-029basic care nicotineNicotine PolacrilexAmazon.com Services LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22587SUPPL2014-08-05
22586ORIG2007-07-06