FDA.reportPublic FDA data

Application 213268

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VARENICLINE TARTRATEVARENICLINE TARTRATETABLET;ORALEQ 0.5MG BASENoNo
002VARENICLINE TARTRATEVARENICLINE TARTRATETABLET;ORALEQ 1MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213268-001VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORAL2025-05-21
A213268-002VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 1MG BASETABLET / ORAL2025-05-21

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
2026-02-19 14:30 UTC2026-02A213268-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORAL2025-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213268-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORAL2025-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213268-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORAL2025-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213268-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORAL2025-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213268-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2025-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213268-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2025-05-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213268-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORAL2025-05-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213268-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORAL2025-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A213268-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213268-002AB16a471c1ec25d…

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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Varenicline tartrateVARENICLINE TARTRATEA-S Medication Solutionse10d320a-adf2-4f1d-a576-9685e45512302026-06-22Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAjanta Pharma USA Inc.2f86bb7b-c6a6-4915-8ba1-17251540971c2026-06-19Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEREMEDYREPACK INC.d759167f-e0b2-46d5-a34a-3c8858e395902026-04-29Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEMarlex Pharmaceuticals, Inc.29b6b4ca-aeef-1295-e063-6394a90a21b92026-03-23Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEPar Health USA, LLC9e5c0ef3-3179-4d7b-bc76-901473c73ce82026-02-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
CHANTIXVARENICLINE TARTRATEPfizer Laboratories Div Pfizer Incf0ff4f27-5185-4881-a749-c6b7a0ca56962026-01-23Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEAvKARE0552d7ff-9fe8-9c9f-e063-6394a90a79fe2026-01-19Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEGlenmark Pharmaceuticals Inc., USAe8a06e8e-1938-412c-a98a-28f0a29fe3ac2026-01-07Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAmerican Health Packaging16a03b5e-03e0-4b0b-92a4-aaf0669906f72025-12-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAmerican Health Packaging38be1217-cd55-416a-bf4b-6ede6bfd37272025-12-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATELupin Pharmaceuticals, Inc.bf20c4cc-1731-4873-8de1-b93d17591e9f2025-12-03Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEMicro Labs Limitedee603a5d-9a3c-4dbd-ba89-faf253dc8c422025-10-31Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATEKanchan Healthcare Inc1624125c-a0c7-49ee-be00-9bfae4ff9bf52025-10-14Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEDr. Reddys Laboratories Inc.16ee0a83-88d7-97de-1e07-f9e6dcb5c9342025-04-25Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATELeading Pharma, LLCfdb36cfa-d20a-4fd9-b994-a5d16e4bb4382024-11-28Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEFlorida Pharmaceutical Products, LLC2b9c8b1e-6193-4d8e-9b50-6aca272942632024-11-05Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
Varenicline tartrateVARENICLINE TARTRATEIndoco Remedies Limitedcd83bc6c-20f4-42e1-adb4-a3d1d89413f42024-11-04Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATENorthStar RxLLC9031aa0d-2f68-4b9d-903f-ac0e95cbf35f2024-09-27Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEA-S Medication Solutions6351047a-9896-4a30-8e49-4d306ce9c9c02024-06-14Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEA-S Medication Solutions2d5dfa6e-e69d-414a-8ff2-44714debbbe22024-04-29Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE