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 5 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare nicotineNICOTINE POLACRILEXTopco Associates LLCc3c52b83-fdbe-4999-b982-37c63462eb7c2026-06-30WarningsName fallback
generic name: NICOTINE POLACRILEX
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCf0f79275-c27a-4d35-a79a-53b0905c37612026-06-29WarningsName fallback
generic name: NICOTINE POLACRILEX
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc768e3f3d-d867-4574-8a5d-07572e2e4a042026-06-29WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E B9bf10dfc-c6df-4cc9-ba79-2dcf874a29042026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyb8cbb6a7-aeb4-48f3-a0ed-7ad8030217522026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E Ba1f36614-539f-45db-aad4-1b300c60bf432026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E B55defc7f-f91d-46eb-8558-2ab1b69ec6a12026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXKroger Company35f45900-af2e-4b74-9772-8beb552364572026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
quitine nicotineNICOTINE POLACRILEXQUITINE LLC21014e98-2c7c-4cc6-8595-a717910710a42026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC060ef0cb-52ef-47b1-bcba-856e443d18a92026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXKroger Companye4a7cf2a-5fd9-4390-8517-e532900ff81c2026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
quitine nicotineNICOTINE POLACRILEXQUITINE LLCfd9ce0e2-b159-4e0d-a76e-7223d36810fb2026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC44cce141-dd0e-47ba-b7fe-7cd6f7935ba52026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXKroger Company0ef57432-471d-4c7a-b8be-0f898f01d1972026-06-26WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXKroger Company1d55fe3e-9c41-409f-8b1d-3c02688903e92026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXKroger Company7295628f-3a9c-4e64-855b-0511aba641752026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXKroger Company37ad9304-7a00-4ec0-bbbb-cf133e0e8bc82026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX
HEB NicotineNICOTINE POLACRILEXH E B9e74cde3-4819-4868-b47e-fe6d1362fa592026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC949d429c-3af3-4512-b742-2bfbf4701c342026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXMeijer Distribution Inc6627f4e3-1c62-43af-be58-df67f7a2dcaa2026-06-25WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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