FDA.reportPublic FDA data

Application 074612

Type
ANDA
Sponsor
AVEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HRNoNo
002NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HRNoNo
003NICOTINENICOTINEFILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1240Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1240Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1241Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1241Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1242Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1242Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1243Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1244Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-1245Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8000Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8001Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0363-8002Nicotine Transdermal SystemNicotine Transdermal SystemWalgreensANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5894NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5895NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
0536-5896NicotineNicotineRugby LaboratoriesANDACurrent
11822-1603Nicotine Transdermal SystemNicotine Transdermal SystemRite Aid CorporationANDACurrent
11822-1603Nicotine Transdermal SystemNicotine Transdermal SystemRite Aid CorporationANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-032Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-034Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
36800-038Nicotine Transdermal SystemNicotine Transdermal SystemTopco Associates LLCANDACurrent
37808-122Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-122Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-123Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-123Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-460Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
37808-461Nicotine Transdermal SystemNicotine Transdermal SystemH-E-BANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-352Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-353Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-354Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CoANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
46122-568Nicotine Transdermal SystemNicotine Transdermal SystemAmerisourceBergen Drug CorporationANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1148NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1694NicotineNicotineA-S Medication SolutionsANDACurrent
50090-1697NicotineNicotineA-S Medication SolutionsANDACurrent