FDA.reportPublic FDA data

Application 078546

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078546-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2007-05-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078546-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2007-05-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078546-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2007-05-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078546-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2007-05-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078546-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2007-05-24a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyb8cbb6a7-aeb4-48f3-a0ed-7ad8030217522026-06-26WarningsExact identifier
application applno (ANDA): 078546
application number: ANDA078546
ndc (product): 0113-0854
NicotineNICOTINE POLACRILEXMeijer Distribution Inc59ba5cba-be1e-4708-a9ab-01f43543bb5b2026-06-19WarningsExact identifier
application applno (ANDA): 078546
application number: ANDA078546
ndc (product): 41250-854
Care One NicotineNICOTINE POLACRILEXAmerican Sales Company78cf8b14-cdad-464c-afb5-9fc49ebc39212026-06-19WarningsExact identifier
application applno (ANDA): 078546
application number: ANDA078546
ndc (product): 41520-854
quitine nicotineNICOTINE POLACRILEXQUITINE LLC426e7bbc-cf58-4be0-a8e5-30a8f7ca5b482026-05-20WarningsExact identifier
application applno (ANDA): 078546
application number: ANDA078546
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC0f1b3cc6-98df-4e34-91f3-dc251fe170f82026-04-28WarningsExact identifier
application applno (ANDA): 078546
application number: ANDA078546

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0854Good Sense NicotineNicotine polacrilexL. Perrigo CompanyANDACurrent
0113-0854Good Sense NicotineNicotine polacrilexL. Perrigo CompanyANDACurrent
0113-0854Good Sense NicotineNicotine polacrilexL. Perrigo CompanyANDACurrent
0113-0854Good Sense NicotineNicotine polacrilexL. Perrigo CompanyANDACurrent
0363-0854NicotineNicotine polacrilexWalgreen CompanyANDACurrent
0363-0854NicotineNicotine polacrilexWalgreen CompanyANDACurrent
11673-854Up and Up NicotineNicotine polacrilexTarget CorporationANDACurrent
11822-0854NicotineNicotine polacrilexRite Aid CorporationANDACurrent
11822-0854NicotineNicotine polacrilexRite Aid CorporationANDACurrent
11822-0854NicotineNicotine polacrilexRite Aid CorporationANDACurrent
21130-168signature care nicotineNicotine polacrilexSafewayANDACurrent
30142-854NicotineNicotine polacrilexKroger CompanyANDACurrent
30142-854NicotineNicotine polacrilexKroger CompanyANDACurrent
36800-854Topcare nicotineNicotine polacrilexTopco Associates LLCANDACurrent
36800-854Topcare nicotineNicotine polacrilexTopco Associates LLCANDACurrent
37808-854In Control NicotineNicotine polacrilexH E BANDACurrent
41250-854NicotineNicotine polacrilexMeijer Distribution IncANDACurrent
41250-854NicotineNicotine polacrilexMeijer Distribution IncANDACurrent
41520-854Care One NicotineNicotine polacrilexAmerican Sales CompanyANDACurrent
41520-854Care One NicotineNicotine polacrilexAmerican Sales CompanyANDACurrent
41520-854Care One NicotineNicotine polacrilexAmerican Sales CompanyANDACurrent
42884-854Zonnic NicotineNicotine polacrilexNiconovum USA Inc.ANDACurrent
46122-666good neighbor pharmacy nicotineNicotine polacrilexAmerisource BergenANDACurrent
46122-666good neighbor pharmacy nicotineNicotine polacrilexAmerisource BergenANDACurrent
49035-854Equate NicotineNicotine polacrilexWal-Mart Stores IncANDACurrent
49035-854Equate NicotineNicotine polacrilexWal-Mart Stores IncANDACurrent
49035-854Equate NicotineNicotine polacrilexWal-Mart Stores IncANDACurrent
59779-854nicotineNicotine polacrilexCVS PharmacyANDACurrent
62011-0426health mart nicotine polacrilexNicotine polacrilexStrategic Sourcing Services LLCANDACurrent
62011-0426health mart nicotine polacrilexNicotine polacrilexStrategic Sourcing Services LLCANDACurrent
62011-0426health mart nicotine polacrilexNicotine polacrilexStrategic Sourcing Services LLCANDACurrent
68196-004members mark nicotineNicotine polacrilexSam's West IncANDACurrent
70677-0086sunmark nicotineNicotine polacrilexStrategic Sourcing Services LLCANDACurrent
70677-0086sunmark nicotineNicotine polacrilexStrategic Sourcing Services LLCANDACurrent
70677-0086sunmark nicotineNicotine polacrilexStrategic Sourcing Services LLCANDACurrent