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 2 of 26 · 518 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXWalgreens97ce52b1-d98e-4216-99c2-7e341c8fec432026-08-25WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmazon.com Services LLC4ab742f2-2599-4d9f-83c5-9338d66ad6cf2026-08-24WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXCardinal Health 107, LLCebab2c3a-4fda-40d6-8f54-972e1c6ee69a2026-08-24WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCb957f757-2b34-49b2-a68b-a7bc9e8dd8b22026-08-21WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXWalgreen Company5dd116ea-d031-439c-b06c-2f77230bc4462026-08-20WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXAmazon.com Services LLCe40a534e-8083-454d-9667-826bfbac397c2026-08-19WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXAmazon.com Services LLCbc1b6b41-d069-470e-90ca-a441ab97f96a2026-08-18WarningsName fallback
generic name: NICOTINE POLACRILEX
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsName fallback
generic name: NICOTINE POLACRILEX
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC4cc32b8c-6316-4d4b-8fa9-ef640464ca692026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC10e3e1ac-2f78-4ce4-8f38-a283fac996602026-08-06WarningsName fallback
generic name: NICOTINE POLACRILEX
nicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecd78195-2df2-401d-b590-2c1cb764df5c2026-08-05WarningsName fallback
generic name: NICOTINE POLACRILEX
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf97d6b-6ca7-48c1-8c37-029421689cc12026-08-05WarningsName fallback
generic name: NICOTINE POLACRILEX

Reported adverse events (FAERS/openFDA)#

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