FDA.reportPublic FDA data

Application 212057

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 2MG BASENoNo
002NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69842-964Nicotine Mininicotine polacrilexCVS PharmacyANDACurrent
69842-964Nicotine Mininicotine polacrilexCVS PharmacyANDACurrent
69842-976Nicotine Mininicotine polacrilexCVS PharmacyANDACurrent
69842-976Nicotine Mininicotine polacrilexCVS PharmacyANDACurrent