FDA.reportPublic FDA data

Application 215276

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 2MG BASENoNo
002NICOTINE POLACRILEXNICOTINE POLACRILEXTROCHE/LOZENGE;ORALEQ 4MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215276-001HABITROLNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-17
A215276-002HABITROLNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215276-001HABITROLEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-1784e616aacf4f…
2026-09-14 22:38:342026-08A215276-002HABITROLEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-1784e616aacf4f…
2026-08-18 06:07:402026-07A215276-001HABITROLEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-17caaa826d4ba7…
2026-08-18 06:07:402026-07A215276-002HABITROLEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215276-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215276-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215276-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215276-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215276-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215276-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215276-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2025-07-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215276-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2025-07-17a50c72e98297…

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 14 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up nicotine mini mintNICOTINE POLACRILEXTarget Corporation43f9d241-3af1-46cb-abe9-8c25427472aa2026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX
Up and Up Mini NicotineNICOTINE POLACRILEXTarget Corporationa15b247e-cf4f-4802-a6e4-24750ea3809b2026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461227b789f4c-7786-4b32-9460-69de57e0a3aa2026-03-17WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461226432c7fc-02d3-42a4-bd46-d48250a1d4d22026-03-16WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensfe5c4bfd-a792-4923-b2db-16be44d599ea2026-03-12WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612239640129-2d7a-4ec5-81a1-e14b11d3d3ee2026-03-12WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E Bb1a13942-1fad-40da-8664-f70574b950d72026-03-11WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXHyVee Incb9257174-fbd4-453d-aa23-77d5a8f91b892026-03-11WarningsName fallback
generic name: NICOTINE POLACRILEX
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc049d2c75-9b7f-4248-81e9-e2973a4cab5d2026-03-03WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXWalgreen Companye5a8974f-d402-4390-8b80-b896b094a0592026-03-03WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E B1fb02f5e-56af-47ef-a1bc-49a6d86cc70c2026-03-03WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreen Companydc1ffb6b-0865-4854-bbbd-97606995e3f42026-03-02WarningsName fallback
generic name: NICOTINE POLACRILEX
BLIPNICOTINE POLACRILEXBlip Products, Inc.291649cf-e5a6-4a98-9a9e-c499b55c37ae2026-03-02WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXWalgreen Company97fefc42-5c9d-453e-a0b6-dc7aac5ee8e12026-03-02WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreen Company74f306d4-2a71-48c9-ab98-378260507a9d2026-03-01WarningsName fallback
generic name: NICOTINE POLACRILEX
Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNICOTINE POLACRILEXRugby Laboratoriesb973d045-7791-49c1-9216-4e0d511737352026-02-27WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotine lozengeNICOTINE POLACRILEXH E Bdb78d030-7abf-494f-94ca-4a385f519faf2026-02-27WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXKroger Companyfd67cb75-509c-41d5-8a2c-6c5fc53bf5132026-02-26WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXRite Aid Corporationef409dfa-94fa-4dfb-8916-e315bec9de342026-02-25WarningsName fallback
generic name: NICOTINE POLACRILEX
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc0eb7bd68-7260-404c-a928-7898c6c265722026-02-23WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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