FDA.reportPublic FDA data

Application 078968

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 1.

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
A078968-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-233f01610625f2…
2019-09-15 20:21 UTC2019-09A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23cb3db0bc1861…

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 26 · 508 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC10e3e1ac-2f78-4ce4-8f38-a283fac996602026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecd78195-2df2-401d-b590-2c1cb764df5c2026-08-05WarningsName fallback
generic name: NICOTINE POLACRILEX
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a92026-08-04WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLC634e50f9-92bb-43be-bd90-360d67d174eb2026-08-04WarningsName fallback
generic name: NICOTINE POLACRILEX
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC48230756-9448-4957-82a6-5e7e3c2c0b572026-08-03WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-07-28WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXRite Aid Corporationcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b2026-07-24WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inc4ddba70a-3f45-4c76-a12a-6da256e9afc52026-07-23WarningsName fallback
generic name: NICOTINE POLACRILEX
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCc6c9582c-004d-4925-b147-add5f28f38562026-07-23WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXCVS Pharmacyab1407e3-9092-438c-b684-8194e4ee71af2026-07-23WarningsName fallback
generic name: NICOTINE POLACRILEX
Up and Up NicotineNICOTINE POLACRILEXTarget Corporationa4bf013b-286b-486c-bb8f-2defb3881d4c2026-07-23WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Incecdfe02c-813b-4c1e-9e02-d7c544a896442026-07-23WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Incfd93fdf4-fa48-4373-aac7-894866a0b18d2026-07-22WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inc00b40bb3-3785-4a53-804e-633795e87f712026-07-20WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-07-20WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXRugby Laboratories621eb214-0716-4306-829f-6185a77f24d52026-07-16WarningsName fallback
generic name: NICOTINE POLACRILEX
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc2eca67db-1b7c-43dd-91af-4060e9b8e9d32026-07-15WarningsName fallback
generic name: NICOTINE POLACRILEX

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11673-652up and up nicotineNicotine polacrilexTarget CorporationANDACurrent