FDA.report

Application 079038

Type
ANDA
Sponsor
P AND L

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9310NicotineNicotine PolacrilexWalgreensANDACurrent
0363-9310NicotineNicotine PolacrilexWalgreensANDACurrent
0363-9310NicotineNicotine PolacrilexWalgreensANDACurrent
0363-9310NicotineNicotine PolacrilexWalgreensANDACurrent
0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNicotine PolacrilexRugby LaboratoriesANDACurrent
0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3387Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
11822-3337NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3337NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3337NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3337NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3337NicotineNicotine PolacrilexRite Aid CorporationANDACurrent
55301-504Nicotine PolacrilexNicotine PolacrilexAAFES/Your Military ExchangesANDACurrent
55301-504Nicotine PolacrilexNicotine PolacrilexArmy and Air Force Exchange ServiceANDACurrent
55301-504Nicotine PolacrilexNicotine PolacrilexAAFES/Your Military ExchangesANDACurrent
55301-504Nicotine PolacrilexNicotine PolacrilexAAFES/Your Military ExchangesANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublixANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublixANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-504Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
63739-368NicotineNicotine PolacrilexMcKesson Corporation dba SKY PackagingANDACurrent
63739-368NicotineNicotine PolacrilexMcKesson Corporation dba SKY PackagingANDACurrent
63868-842NicotineNicotine PolacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-842NicotineNicotine PolacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-842NicotineNicotine PolacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
66715-9802Nicotac Nicotine PolacrilexNicotineLil' Drug Store Products, Inc.ANDACurrent
66715-9802Nicotac Nicotine PolacrilexNicotineLil' Drug Store Products, Inc.ANDACurrent
66715-9802Nicotac Nicotine PolacrilexNicotineLil' Drug Store Products, Inc.ANDACurrent
66715-9802Nicotac Nicotine PolacrilexNicotineLil' Drug Store Products, Inc.ANDACurrent
68196-016Nicotine Coated Fruit Flavornicotine polacrilexSam's West, Inc.ANDACurrent
68196-016Nicotine Coated Fruit Flavornicotine polacrilexSam's West, Inc.ANDACurrent
68196-016Nicotine Coated Fruit Flavornicotine polacrilexSam's West, Inc.ANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-025Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health, Inc.ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0342Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent

Documents

DocumentSubmission typeDate
22633ORIG2013-02-25