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 4 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companybfdf3918-3116-4351-b0a8-4c515e2e1f412026-07-14WarningsName fallback
generic name: NICOTINE POLACRILEX
Kirkland Signature Quit 2NICOTINE POLACRILEXCostco Wholesale Company17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c12026-07-14WarningsName fallback
generic name: NICOTINE POLACRILEX
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companyb9dd4e89-0023-4552-bdd6-1c046ce3bd872026-07-14WarningsName fallback
generic name: NICOTINE POLACRILEX
coated nicotineNICOTINE POLACRILEXPublix Super Markets Inc97b06ada-b8b8-49fc-bc65-c3e835ef149b2026-07-13WarningsName fallback
generic name: NICOTINE POLACRILEX
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inc61c69497-91f9-45bf-ad48-33ac73e63a752026-07-10WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsName fallback
generic name: NICOTINE POLACRILEX
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6b0342dd-120f-a16e-098a-dc45b14d3d3a2026-07-09WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
Mini NicotineNICOTINE POLACRILEXRite Aid Corporation353221c6-96c7-4c4b-a114-03e71d2114f82026-07-07WarningsName fallback
generic name: NICOTINE POLACRILEX
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsName fallback
generic name: NICOTINE POLACRILEX
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC03d9708a-923c-4fd3-ac3d-6ab4a4d8a8042026-06-30WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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