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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A078968-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2008-04-23caaa826d4ba7…
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…

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 25 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc265e7411-45cd-4bd2-98fc-0401dfa524342023-07-28WarningsName fallback
generic name: NICOTINE POLACRILEX
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc43a24aa7-ba1c-4c5d-9ec8-ed496e299e002023-07-28WarningsName fallback
generic name: NICOTINE POLACRILEX
equate nicotineNICOTINE POLACRILEXWALMART INC.0f625e1a-be08-4460-a588-8b42282ac1212023-06-15WarningsName fallback
generic name: NICOTINE POLACRILEX
topcare nicotineNICOTINE POLACRILEXTopco Associates LLC872d8ba6-881c-49f2-9848-1ed3eed768602023-06-15WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreen Companyd2572335-9c54-4745-9a11-eb9b8d34d0cd2023-06-14WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXWalgreen Company8af06c23-80b7-4559-b594-a3a02297306d2023-05-28WarningsName fallback
generic name: NICOTINE POLACRILEX
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companycb462e10-124e-4ea3-9261-8c1fc7a9e1a62023-05-18WarningsName fallback
generic name: NICOTINE POLACRILEX
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companycd1c3493-242c-4981-8561-ebbea938628f2023-05-12WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreen Company1123afbb-1785-43f0-aca4-dd5a9565d7742023-04-10WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab184645-6fff-40cf-9859-4b8dec9098b22023-03-20WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab1df1b4-a831-4de2-be87-38b9cd589db92023-03-20WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)4eeaf22c-a839-49c5-b099-77321d590d062022-12-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc8c66eb21-dd95-4dcb-8488-e1e768dd8cd62022-12-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy4853ee32-521f-4359-8084-438893be43bc2022-11-22WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXCVS Pharmacy7fa848c6-3a4a-41f3-b927-1b26b6232e3a2022-11-22WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy8332bb07-72a7-491e-a19b-baff84acefdb2022-11-22WarningsName fallback
generic name: NICOTINE POLACRILEX
signature care nicotineNICOTINE POLACRILEXSafewaycb2624de-3908-4091-aea1-f0dc76abd6332022-11-15WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 7000071ee5a44-b451-4ecd-9fe7-8124b4dae1c52022-10-20WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 700006edf8c50-d3b9-469a-ad57-37c05e0988622022-10-20WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXAurohealth LLC810932e0-a982-400a-b43d-b847152f685b2022-06-24WarningsName fallback
generic name: NICOTINE POLACRILEX

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 · 1 matching rows.

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