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 8 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care nicotineNICOTINE POLACRILEXSafeway3591828f-dff0-4cb7-ab0e-d43704243dc22026-06-12WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E Bbbc4fd9f-b1f5-4691-b980-3424c91e4c882026-06-12WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXH E B8c288d15-d1ea-42b6-8cfb-f056d59fd3e02026-06-12WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf9759891-7d3d-4714-8f8b-92d0a499e52e2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
members mark nicotineNICOTINE POLACRILEXSam's West Inc2c43a498-a4fb-4ed1-b4ae-aecfd334945b2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
blipNICOTINE POLACRILEXBlip Products, Inc.451863c3-4c17-448e-9225-a5492344af152026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
members mark nicotineNICOTINE POLACRILEXSam's West Inc8828d4f5-7b3a-4f1c-8f78-fa820ffa84412026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
members mark nicotineNICOTINE POLACRILEXSam's West Inc8edad777-6491-4ab2-9835-709bf54d5f0c2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
members mark nicotineNICOTINE POLACRILEXSam's West Inc0ea1d300-d77a-4262-b74c-583455606a2c2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
Members Mark NicotineNICOTINE POLACRILEXSam's West Incbb8ec4c2-7f1a-4069-9677-8bf645d18e322026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
BLIPNICOTINE POLACRILEXBlip Products, Inc.ad5fc90e-d3b4-4701-bfd8-1cda9087d09a2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
dg health nicotineNICOTINE POLACRILEXDolgencorp Inc64b2982d-491e-42e7-b65e-7abf5530b9352026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltd26edb714-656d-49ca-b875-28972c490e5f2026-06-11WarningsName fallback
generic name: NICOTINE POLACRILEX
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLCa7e3da43-693b-44df-8566-4847edae9d612026-06-10WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc6b806a-f571-4d33-9b93-3dcd21ad02602026-06-09WarningsName fallback
generic name: NICOTINE POLACRILEX
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC63ac801f-02ed-43a1-a2a8-2ad35d8fd7a92026-06-09WarningsName fallback
generic name: NICOTINE POLACRILEX
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC90f2da70-c58f-44fb-bdbd-5c95440c11982026-06-08WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXRite Aid Corporation8b24aefd-1881-4126-9188-29896a17a06d2026-06-03WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXHyVee Inc7e391e5d-a715-42ae-8c4d-0a7d1a8599892026-06-03WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXCVS Pharmacy4bc94e0b-189f-47b0-826c-2ccf6c4a0e3a2026-06-01WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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