FDA.reportPublic FDA data

Application 201808

Type
ANDA
Sponsor
WATSON LABS INC

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.

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vareniclineVARENICLINE TARTRATEA-S Medication Solutions2d5dfa6e-e69d-414a-8ff2-44714debbbe22024-04-29Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEMajor Pharmaceuticals1297c291-da28-4a73-9c28-d5adee36d7b72023-12-15Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATECamber Pharmaceuticals, Inc.7bd1abc8-2689-496b-b3f2-1cefe218ff5a2023-11-08Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
CHANTIXVARENICLINE TARTRATEProficient Rx LP0fefd790-b526-4f2f-8c83-5f39f73065562020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
CHANTIXVARENICLINE TARTRATEProficient Rx LPf22e3aef-714b-4014-8d77-83ee03fd1f572020-01-01Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
CHANTIXVARENICLINE TARTRATEAphena Pharma Solutions - Tennessee, LLCb4403cea-6300-4d89-8fde-5149a80b08b92017-12-18Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE

Reported adverse events (FAERS/openFDA)#

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