FDA.report

Application 074507

Type
ANDA
Sponsor
P AND L

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 2MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreen CompanyANDACurrent
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1608Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-9290Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9290Nicotinenicotine polacrilexWalgreensANDACurrent
0536-3029Rugby Nicotine Polacrilex Gum, Original FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3029Rugby Nicotine Polacrilex Gum, Original FlavorNicotine PolacrilexRugby LaboratoriesANDACurrent
0536-3029Rugby Nicotine Polacrilex Gum, Original FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3029Rugby Nicotine Polacrilex Gum, Original FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-3029Rugby Nicotine Polacrilex Gum, Original FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
11822-3328Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3328Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
30142-859Nicotinenicotine polacrilexThe Kroger Co.ANDACurrent
46122-719Nicotinenicotine polacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublix Supermarkets, Inc.ANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublixANDACurrent
56062-608Nicotine PolacrilexNicotine PolacrilexPublixANDACurrent
63739-371Nicotinenicotine polacrilexMcKesson Corporation dba SKY PackagingANDACurrent
63739-371Nicotinenicotine polacrilexMcKesson Corporation dba SKY PackagingANDACurrent
63868-849Nicotinenicotine polacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-849Nicotinenicotine polacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
68016-286Nicotine Polacrilex, OriginalNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-286Nicotine Polacrilex, OriginalNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-286Nicotine Polacrilex, OriginalNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-286Nicotine Polacrilex, OriginalNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-286Nicotine Polacrilex, OriginalNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68196-010Nicotinenicotine polacrilexSam's West, Inc.ANDACurrent
68196-010Nicotinenicotine polacrilexSam's West, Inc.ANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
69842-608Nicotine PolacrilexNicotine PolacrilexCVS PharmacyANDACurrent
70000-0345Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0345Nicotine PolacrilexNicotine PolacrilexCardinal Health, Inc.ANDACurrent
70000-0345Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0345Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent

Documents

DocumentSubmission typeDate
18358ORIG2004-06-10
42849ORIG2003-04-30
8417ORIG1999-03-15