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 12 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Up and Up Mint NicotineNICOTINE POLACRILEXTarget Corporationb66279c0-e285-4e49-88b3-53c66d2ece212026-04-16WarningsName fallback
generic name: NICOTINE POLACRILEX
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc53387dd6-28c0-412d-bc74-4d323c8d5e112026-04-16WarningsName fallback
generic name: NICOTINE POLACRILEX
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCa0238a02-26eb-4cde-8ff7-a5f0d26dd1752026-04-16WarningsName fallback
generic name: NICOTINE POLACRILEX
up and up uncoated mint nicotineNICOTINE POLACRILEXTarget Corporation816cc4f7-b7ef-4172-b16b-e9c1dc3564822026-04-16WarningsName fallback
generic name: NICOTINE POLACRILEX
CareOne NicotineNICOTINE POLACRILEXAmerican Sales Company74ec6a60-eb3a-47d4-a11b-650b6418d37f2026-04-14WarningsName fallback
generic name: NICOTINE POLACRILEX
up and up cherry ice nicotineNICOTINE POLACRILEXTarget Corporation99977d30-41ba-4237-920a-dbd5ad8fc3802026-04-14WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXMeijer, Inc.34107c14-6ece-4a51-b53f-ee0099889e992026-04-14WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex Coated MintNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700002c420ee4-0ed0-4a3f-bc92-202d825d0ca32026-04-13WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex Coated Ice MintNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 70000b075c3cb-d610-4a9c-8cf0-e4b9001bc86a2026-04-13WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXCVS Pharmacy65ceb67b-dc22-4f5f-bfce-d6e957835eb32026-04-13WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex Coated FruitNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 70000d6c7a2ab-109d-40df-bce0-30c3531eb9822026-04-10WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine Polacrilex OriginalNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700004acbda22-9c87-49f2-ad5f-55b1e54bdf2e2026-04-10WarningsName fallback
generic name: NICOTINE POLACRILEX
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyba373c62-65eb-43ad-88e3-bb2c13df588c2026-04-10WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXMeijer Distribution Inc3566423d-3ddb-4913-9da5-fb43680f0efc2026-04-08WarningsName fallback
generic name: NICOTINE POLACRILEX
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf2026-04-08WarningsName fallback
generic name: NICOTINE POLACRILEX
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company74ce5bd9-98ad-4e41-80b0-5d7aaa122ac82026-04-08WarningsName fallback
generic name: NICOTINE POLACRILEX
good sense nicotineNICOTINE POLACRILEXL. Perrigo Company1e2631b6-b99e-4345-840e-9ddd0873a4212026-04-07WarningsName fallback
generic name: NICOTINE POLACRILEX
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc519788c4-10fc-4395-9114-74e996e103fa2026-04-07WarningsName fallback
generic name: NICOTINE POLACRILEX
careone nicotineNICOTINE POLACRILEXAmerican Sales Company97926c62-b56a-4ce0-addb-037d90d297e72026-04-03WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXH E B056ca637-d5b9-4790-a5a4-c9b58f93e88b2026-04-02WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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