FDA.reportPublic FDA data

Application 209206

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
0363-9570Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9570Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9570Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9570Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9570Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9580Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9580Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9580Nicotinenicotine polacrilexWalgreensANDACurrent
0363-9580Nicotinenicotine polacrilexWalgreensANDACurrent
0536-1337Nicotinenicotine polacrilexRugby Laboratories, Inc.ANDACurrent
0536-1337Nicotinenicotine polacrilexRugby Laboratories, Inc.ANDACurrent
0536-1338Maxi Nicotinenicotine polacrilexRugby Laboratories, Inc.ANDACurrent
0536-1338Maxi Nicotinenicotine polacrilexRugby Laboratories, Inc.ANDACurrent
11822-3316Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3316Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3316Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3316Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3317Maxi Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3317Maxi Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3317Maxi Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
11822-3317Maxi Nicotinenicotine polacrilexRite Aid CorporationANDACurrent
46122-732Nicotinenicotine polacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-734Nicotinenicotine polacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
69842-858Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-858Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-858Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-858Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-858Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-957Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-957Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-957Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-957Nicotinenicotine polacrilexCVS PharmacyANDACurrent
69842-957Nicotinenicotine polacrilexCVS PharmacyANDACurrent
70000-0561Maxi Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0561Maxi Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0561Maxi Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0562Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0562Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0562Nicotinenicotine polacrilexCardinal Health (Leader) 70000ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54892ORIG2018-07-16