FDA.reportPublic FDA data

Application 204833

Type
ANDA
Sponsor
P AND L

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
A204833-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-02-26

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 UTC2022-10A204833-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204833-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-02-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204833-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-02-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204833-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2016-02-26a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Polacrilex Coated Ice MintNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 70000b075c3cb-d610-4a9c-8cf0-e4b9001bc86a2026-04-13WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
ndc (product): 70000-0344
Nicotine PolacrilexNICOTINE POLACRILEXChain Drug Consortium, LLC9c115cd5-1952-4f1e-8e88-27f2c528e91f2026-03-26WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
ndc (product): 68016-293
Nicotine PolacrilexNICOTINE POLACRILEXFamily Dollar (FAMILY WELLNESS)d353b75f-3fc3-4958-92c6-08df6bdf283c2026-03-18WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
Nicotine Polacrilex coated ice mintNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122c21147f5-da96-424c-9058-24eb751b64ea2026-03-17WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
ndc (product): 46122-449
Nicotine PolacrilexNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ee883114-35ac-4b81-b8f1-4903d646dd842026-02-11WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
Nicotine PolacrilexNICOTINE POLACRILEXWalgreens5741531a-3886-4b0a-ae92-d7c238488fdf2026-02-04WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
ndc (product): 0363-3290
Nicotine Polacrilex coated ice mintNICOTINE POLACRILEXCVS Pharmacye4e3fd5f-1ed1-4a18-9c31-7224cae77ded2024-10-03WarningsExact identifier
application applno (ANDA): 204833
application number: ANDA204833
ndc (product): 69842-217

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 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0613Nicotine PolacrilexNicotine PolacrilexWalgreen CompanyANDACurrent
0363-0613Nicotine PolacrilexNicotine PolacrilexWalgreen CompanyANDACurrent
0363-3290Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-3290Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
0363-3290Nicotine PolacrilexNicotine PolacrilexWalgreensANDACurrent
11822-3314Nicotine PolacrilexNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3314Nicotine PolacrilexNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3314Nicotine PolacrilexNicotine PolacrilexRite Aid CorporationANDACurrent
11822-3314Nicotine PolacrilexNicotine PolacrilexRite Aid CorporationANDACurrent
46122-449Nicotine PolacrilexNicotine PolacrilexAMERISOURCE BERGENANDACurrent
46122-449Nicotine PolacrilexNicotine PolacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-449Nicotine PolacrilexNicotine PolacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-449Nicotine PolacrilexNicotine PolacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
46122-449Nicotine PolacrilexNicotine PolacrilexAmerisourceBergen (Good Neighbor Pharmacy) 46122ANDACurrent
49035-613Nicotine PolacrilexNicotine PolacrilexWal-Mart Stores IncANDACurrent
49035-613Nicotine PolacrilexNicotine PolacrilexEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-613Nicotine PolacrilexNicotine PolacrilexEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
63868-843NicotineNicotine PolacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-843NicotineNicotine PolacrilexQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
68016-293Nicotine PolacrilexNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-293Nicotine PolacrilexNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-293Nicotine PolacrilexNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-293Nicotine PolacrilexNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68016-293Nicotine PolacrilexNicotine PolacrilexChain Drug Consortium, LLCANDACurrent
68196-014Nicotine COATED ice mintnicotine polacrilexSam's West, Inc.ANDACurrent
68196-014Nicotine COATED ice mintnicotine polacrilexSam's West, Inc.ANDACurrent
68196-014Nicotine COATED ice mintnicotine polacrilexSam's West, Inc.ANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
69842-217Nicotine PolacrilexNicotine Polacrilex GumCVS PharmacyANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health, Inc.ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent
70000-0344Nicotine PolacrilexNicotine PolacrilexCardinal Health (Leader) 70000ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32598ORIG2016-02-29