FDA.reportPublic FDA data

Application 210711

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
0363-0979NicotineNicotine PolacrilexWalgreensANDACurrent
0363-0979NicotineNicotine PolacrilexWalgreensANDACurrent
0363-5760Nicotinenicotine polacrilexWalgreensANDACurrent
0363-5760Nicotinenicotine polacrilexWalgreensANDACurrent
0363-5760Nicotinenicotine polacrilexWalgreensANDACurrent
0363-5770NicotineNicotine PolacrilexWalgreensANDACurrent
0363-5770NicotineNicotine PolacrilexWalgreensANDACurrent
0363-5770NicotineNicotine PolacrilexWalgreensANDACurrent
0363-9780Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9780Nicotinenicotine polacrilexWalgreensANDACurrent
11822-0903Mini Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-0903Mini Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-0903Maxi Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-9902Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-9902Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-9902Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
69842-934Mini NicotineNicotine PolacrilexCVS PharmacyANDACurrent
69842-934Mini NicotineNicotine PolacrilexCVS PharmacyANDACurrent