FDA.reportPublic FDA data

Application 076569

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 2MG BASENoNo
002NICOTINE 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
A076569-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29

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 UTC2022-10A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXCardinal Health 107, LLCebab2c3a-4fda-40d6-8f54-972e1c6ee69a2026-08-24WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (product): 0536-1362
Nicotine Polacrilex MINTNICOTINE POLACRILEXWalgreens53c5ae28-5638-4217-9080-2bceba9a88852026-05-19WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (product): 0363-1420
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461225efd7a3c-b36c-4355-a646-bfeb7ba30ce52026-03-17WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (product): 46122-724
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXA-S Medication Solutions7b70162e-0087-466f-9b8b-8289b6e90e392025-09-23WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (product): 50090-3560
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.62609a8d-bcbe-420c-aed8-edfdf022ff262025-06-27WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (product): 17856-1362

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreen CompanyANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-1420Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby LaboratoriesANDACurrent
0536-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexRugby Laboratories, Inc.ANDACurrent
17856-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-1362Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexATLANTIC BIOLOGICALS CORP.ANDACurrent
46122-724Nicotinenicotine polacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent
50090-3560Rugby Nicotine Polacrilex Gum, Mint FlavorNicotine PolacrilexA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31141ORIG2004-07-30