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 13 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXH E B526bc299-657a-4899-aa72-04e151a38cba2026-04-02WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXHyVee Inc9087e72a-6061-4b11-b41d-c9bfd2c20ec32026-03-27WarningsName fallback
generic name: NICOTINE POLACRILEX
nictoine gumNICOTINE POLACRILEXRite Aid Corporation6088eea3-f8f0-4f28-8d38-c2209f2d66262026-03-27WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXRite Aid Corporation4dee260e-784b-40a3-aa79-579c36cfc82c2026-03-27WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex Coated MintNICOTINE POLACRILEXChain Drug Consortium, LLCb4ac0a22-3556-4591-aa7b-e09c6010adc82026-03-26WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXChain Drug Consortium, LLC9c115cd5-1952-4f1e-8e88-27f2c528e91f2026-03-26WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreensdda17eef-cd75-4c82-b468-09111298282d2026-03-25WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXWalgreens826f63b2-fd18-4213-be38-a430d78897cb2026-03-25WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreensd6c6c753-f604-473c-88b4-b5f83f1dd2932026-03-23WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXWalgreens69ffbb37-e26c-4214-8d09-0bbabed253102026-03-20WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)11e537db-7dc7-4b28-97eb-da70c80d8fe32026-03-19WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXHyVee Inc6415ebf4-5b6f-4811-997d-27c76893bc042026-03-19WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612253c82cf8-d97b-4a5a-a357-fb74a74d1ef32026-03-18WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612251cf7563-889d-4726-8f4c-e8efe02904322026-03-18WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612203d0bfa1-cb23-408a-8d8e-24aa0e05bf4f2026-03-18WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
Nicotine PolacrilexNICOTINE POLACRILEXFamily Dollar (FAMILY WELLNESS)d353b75f-3fc3-4958-92c6-08df6bdf283c2026-03-18WarningsName fallback
brand name: Nicotine Polacrilex
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122be693c28-58d5-42ed-ab86-2a28af9310512026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX
up and up mint mini nicotineNICOTINE POLACRILEXTarget Corporationb07f00fe-84da-4d1c-a57f-6579b9f3fb9d2026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex coated ice mintNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122c21147f5-da96-424c-9058-24eb751b64ea2026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461225efd7a3c-b36c-4355-a646-bfeb7ba30ce52026-03-17WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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