FDA.reportPublic FDA data

Application 212879

Type
ANDA
Sponsor
VIWIT PHARM

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
A212879-001VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2025-05-06
A212879-002VARENICLINE TARTRATEVARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2025-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212879-001AB
A212879-002AB

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
2026-08-01 22:54:322026-06A212879-001VARENICLINE TARTRATEEQ 0.5MG BASETABLET / ORALAB2025-05-06a50c72e98297…
2026-08-01 22:54:322026-06A212879-002VARENICLINE TARTRATEEQ 1MG BASETABLET / ORALAB2025-05-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212879-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212879-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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